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Pretty in bloom spf 20 - Medication Information

Product NDC Code 59427-014
Drug Name

Pretty in bloom spf 20

Type Brand
Active Ingredients
Titanium dioxide 25 mg/ml
Zinc oxide 61 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name ORIGINS NATURAL RESOURCES INC.
Packages
Package NDC Code Description
59427-014-01 1 tube in 1 carton (59427-014-01) / 30 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Purpose titanium dioxide 2.5% Sunscreen zinc oxide 6.1% Sunscreen
Active ingredientsPurpose
titanium dioxide 2.5%Sunscreen
zinc oxide 6.1%Sunscreen

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions For sunscreen use: apply generously and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am – 2pm wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water\aqua\eau • dimethicone • phenyl trimethicone • butylene glycol • octyldodecyl neopentanoate • butyloctyl salicylate • isododecane • isopentyldiol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-10 dimethicone • silica • dimethicone/vinyl dimethicone crosspolymer • hydrated silica • cymbopogon martini oil essential oil , pelargonium graveolens flower oil , rosa damascena flower oil , ricinus communis (castor) seed oil, geraniol, citronellol, linalool • hibiscus sabdariffa flower extract • jasminum officinale (jasmine) flower wax • citrus aurantium amara (bitter orange) flower wax • lavandula angustifolia (lavender) flower wax • caffeine • polianthes tuberosa flower wax • ormenis multicaulis flower wax • jasminum officinale (jasmine) flower powder • oryzanol • sodium hyaluronate • helichrysum angustifolium wax • trimethylsiloxysilicate • nymphaea caerulea flower extract • rosa damascena flower wax • alcaligenes polysaccharides • camellia japonica seed oil • rosa centifolia flower powder • passiflora edulis seed oil • carthamus tinctorius (safflower) seed oil • lavandula angustifolia (lavender) flower powder • narcissus poeticus flower wax • corylus avellana (hazel) seed oil • hydrolyzed wheat protein/pvp crosspolymer • acacia dealbata flower wax • honey\mel\miel • rosa centifolia flower wax • laminaria saccharina extract • algae extract • dimethicone silylate • dipentaerythrityl tri-polyhydroxystearate • disteardimonium hectorite • tocopheryl acetate • peg/ppg-18/18 dimethicone • caprylyl glycol • methyl trimethicone • lecithin • sodium pca • methicone • triethoxycaprylylsilane • dimethicone crosspolymer-3 • magnesium sulfate • magnesium aluminum sulfate • magnesium aluminum silicate • propylene carbonate • potassium sorbate • xanthan gum • disodium edta • bht • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln46315>

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps prevent sunburn

Purpose

Information about the drug product’s indications for use.
Active ingredients Purpose titanium dioxide 2.5% Sunscreen zinc oxide 6.1% Sunscreen
Active ingredientsPurpose
titanium dioxide 2.5%Sunscreen
zinc oxide 6.1%Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
PRETTY IN BLOOM SPF 20 titanium dioxide and zinc oxide WATER DIMETHICONE PHENYL TRIMETHICONE BUTYLENE GLYCOL OCTYLDODECYL NEOPENTANOATE BUTYLOCTYL SALICYLATE ISODODECANE ISOPENTYLDIOL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PEG-10 DIMETHICONE (600 CST) SILICON DIOXIDE HYDRATED SILICA PALMAROSA OIL PELARGONIUM GRAVEOLENS FLOWER OIL ROSA X DAMASCENA FLOWER OIL CASTOR OIL GERANIOL .BETA.-CITRONELLOL, (R)- LINALOOL, (+/-)- HIBISCUS SABDARIFFA FLOWER JASMINUM OFFICINALE FLOWER BITTER ORANGE LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER WAX CAFFEINE AGAVE POLIANTHES FLOWER WAX ORYZANOL HYALURONATE SODIUM HELICHRYSUM LITOREUM WHOLE NYMPHAEA CAERULEA FLOWER ROSA X DAMASCENA FLOWER WAX CAMELLIA JAPONICA SEED OIL ROSA CENTIFOLIA FLOWER PASSIFLORA EDULIS SEED OIL SAFFLOWER OIL LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER NARCISSUS POETICUS FLOWER WAX EUROPEAN HAZELNUT OIL ACACIA DEALBATA FLOWER WAX HONEY ROSA CENTIFOLIA FLOWER WAX SACCHARINA LATISSIMA DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE DISTEARDIMONIUM HECTORITE .ALPHA.-TOCOPHEROL ACETATE PEG/PPG-18/18 DIMETHICONE CAPRYLYL GLYCOL METHYL TRIMETHICONE SODIUM PYRROLIDONE CARBOXYLATE METHICONE (20 CST) TRIETHOXYCAPRYLYLSILANE MAGNESIUM SULFATE, UNSPECIFIED FORM MAGNESIUM ALUMINUM SILICATE PROPYLENE CARBONATE POTASSIUM SORBATE XANTHAN GUM EDETATE DISODIUM BUTYLATED HYDROXYTOLUENE PHENOXYETHANOL MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton ORIGINS PRETTY IN BLOOM™ SPF 20 Flower-Infused Long-Wear Foundation Broad Spectrum SPF 20 1 fl. oz./oz. liq./30 ml e PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect the product in this container from excessive heat and direct sun

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API