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| Product NDC Code | 84122-050 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Olivia and allison aqua skin sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Makeup S.he, Inc. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0% Homosalate 7.3% Octisalate 5.0% Octocrylene 8.7%
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 ■ apply liberally 15 minutes before sun exposure. 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 ■ reapply at least every 2 hours. ■ use a water-resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Butyloctyl Salicylate, Cetearyl Alcohol, Poly C10-30 Alkyl Acrylate, Dicaprylyl Carbonate, Cetearyl Glucoside, Niacinamide, Dipropylene Glycol, Sorbitan Olivate, Polymethylsilsesquioxane, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Butylene Glycol, Hydroxypropyl Methylcellulose Stearoxy Ether, Tocopheryl Acetate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Adenosine, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Lonicera Caprifolium (Honeysuckle) Extract, Yeast Extract, Limonia Acidissima Extract, 1,2-Hexanediol, Glycerin, Tocopherol, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Fragrance, Geraniol, Butylphenyl Methylpropional, Linalool, Benzyl Benzoate, Hexyl Cinnamal, Limonene
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 ■ higher SPF gives more sunburn protection ■ if used as directed with other sun protection measures ( see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun
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.Olivia and Allison AQUA SKIN SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene OCTISALATE OCTISALATE DICAPRYLYL CARBONATE ETHYLENE GLYCOL MONOBENZYL ETHER 1,2-HEXANEDIOL ASIATICOSIDE BUTYLPHENYL METHYLPROPIONAL BENZYL BENZOATE AVOBENZONE AVOBENZONE GLYCERYL STEARATE SE ETHOHEXADIOL .ALPHA.-TOCOPHEROL ACETATE CENTELLA ASIATICA TRITERPENOIDS LIMONENE, (+)- .ALPHA.-HEXYLCINNAMALDEHYDE OCTOCRYLENE OCTOCRYLENE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE EDETATE DISODIUM ANHYDROUS XANTHAN GUM GERANIOL CETOSTEARYL ALCOHOL BAMBUSA VULGARIS LEAF CETEARYL GLUCOSIDE ASIATIC ACID WATER MADECASSIC ACID SCLEROMITRION DIFFUSUM BUTYLENE GLYCOL HOMOSALATE HOMOSALATE ETHYLHEXYLGLYCERIN ADENOSINE YEAST GLYCERIN TOCOPHEROL BUTYLOCTYL SALICYLATE NIACINAMIDE DIPROPYLENE GLYCOL SORBITAN OLIVATE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) PANTHENOL ARGININE LINALOOL, (+/-)-
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.MAKEUPSHE_Aaua skin sunscreen
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 products is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ protect the product in this container from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
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 the product keep out of eyes. Rinse with water to remove.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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
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