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Product NDC Code | 79596-006 | ||||||
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Drug Name | Born this way healthy glow spf30 |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | EMULSION | ||||||
Application Number | M020 | ||||||
Labeler Name | TOO FACED COSMETICS LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT OCTINOXATE 5.0% TITANIUM DIOXIDE 3.1% ZINC OXIDE 2.2%
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 10 a.m. – 2 p.m. • 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 [] METHYL TRIMETHICONE [] PHENYL TRIMETHICONE [] SILICA [] BUTYLOCTYL SALICYLATE [] DIMETHICONE [] NEOPENTYL GLYCOL DIHEPTANOATE [] C12-15 ALKYL BENZOATE [] BUTYLENE GLYCOL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] ETHYLHEXYL PALMITATE [] TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER [] GLYCERIN [] POLYSILICONE-11 [] RHODODENDRON FERRUGINEUM EXTRACT [] COCOS NUCIFERA (COCONUT) LIQUID ENDOSPERM [] COCOS NUCIFERA (COCONUT) FRUIT JUICE [] SODIUM HYALURONATE [] THERMUS THERMOPHILLUS FERMENT [] SODIUM PCA [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] LENS ESCULENTA (LENTIL) FRUIT EXTRACT [] CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT [] TOCOPHERYL ACETATE [] LITCHI CHINENSIS SEED EXTRACT [] LECITHIN [] SODIUM LACTATE [] TRIETHYL CITRATE [] PEG-10 DIMETHICONE [] MAGNESIUM ALUMINUM SILICATE [] DIMETHICONE SILYLATE [] DEXTRIN [] TRIETHOXYCAPRYLYLSILANE [] SILICA DIMETHYL SILYLATE [] TRIMETHYLSILOXYSILICATE [] DISODIUM PHOSPHATE [] LAURETH-7 [] DISTEARDIMONIUM HECTORITE [] SODIUM CHLORIDE [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] XANTHAN GUM [] CALCIUM CHLORIDE [] CAPRYLYL GLYCOL [] DIPROPYLENE GLYCOL [] HEXYLENE GLYCOL [] LAMINARIA SACCHARINA EXTRACT [] GLYCINE SOJA (SOYBEAN) PROTEIN [] POLYGLUTAMIC ACID [] ZINC STEARATE [] BHT [] DISODIUM EDTA [] SODIUM CITRATE [] PHENOXYETHANOL [] POTASSIUM SORBATE [] SODIUM DEHYDROACETATE [] SODIUM BENZOATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491) [] IRON OXIDES (CI 77492) [] IRON OXIDES (CI 77499)] <ILN48852>
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.USE HELPS PREVENT SUNBURN
Purpose
Information about the drug product’s indications for use.PURPOSE SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.BORN THIS WAY HEALTHY GLOW SPF30 OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE ETHYLHEXYL PALMITATE RHODODENDRON FERRUGINEUM WHOLE LENS CULINARIS FRUIT CAPRYLYL GLYCOL METHYL TRIMETHICONE PHENYL TRIMETHICONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE SILICON DIOXIDE MAGNESIUM ALUMINUM SILICATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CALCIUM CHLORIDE DIPROPYLENE GLYCOL SOY PROTEIN EDETATE DISODIUM ANHYDROUS PHENOXYETHANOL SODIUM BENZOATE WATER BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE BUTYLENE GLYCOL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE GLYCERIN COCONUT JUICE HYALURONATE SODIUM THERMUS THERMOPHILUS LYSATE APPLE WATERMELON .ALPHA.-TOCOPHEROL ACETATE LITCHI CHINENSIS SEED PEG-10 DIMETHICONE (220 CST) SILICA DIMETHYL SILYLATE LAURETH-7 SODIUM CHLORIDE DIMETHICONE/PEG-10/15 CROSSPOLYMER HEXYLENE GLYCOL SACCHARINA LATISSIMA THALLUS ZINC STEARATE BUTYLATED HYDROXYTOLUENE SODIUM CITRATE SODIUM DEHYDROACETATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE DIMETHICONE NEOPENTYL GLYCOL DIHEPTANOATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) COCONUT WATER SODIUM PYRROLIDONE CARBOXYLATE LECITHIN, SOYBEAN SODIUM LACTATE TRIETHYL CITRATE ICODEXTRIN TRIETHOXYCAPRYLYLSILANE TRIMETHYLSILOXYSILICATE (M/Q 0.66) DISTEARDIMONIUM HECTORITE XANTHAN GUM POTASSIUM SORBATE MICA
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 TOO FACED BORN THIS WAY HEALTHY GLOW 30 SPF MOISTURIZING SKIN TINT WATERMELON + APPLE HYALURONIC ACID BROAD SPECTRUM SPF 30 PROTECTS AGAINST UVA & UVB RAYS 60ML / 2.0 FL. OZ. Principal Display Panel
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 BRONKEN 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 BRONKEN 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