Active Ingredients
Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.
Moisturizer
FDA Label NDC 61354-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development, Llc for the product Moisturizer (NDC 61354-050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use, otc - do not use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
- 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.
Warnings
For external use only.
Stop Use
Stop use and ask doctor if rash occurs.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months:Ask a doctor.
- Apply to all skin exposed to the sun.
- 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. - 2p.m.
-Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
- Protect the product in this container from excessive heat and direct sunlight.
- You may report a serious adverse reaction to: Awake Beauty c/o Reprot Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
Inactive Ingredients
Water, Glyceryl Stearate, Glycerin, Propanediol, Cetearyl Alcohol, Squalane, Stearic Acid,
C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Polyester-8, Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenoxyethanol, Sclerotium Gum, Phenylethyl Resorcinol, Tribehenin, Dimethiconol, Caprylyl Glycol, Chlorphenesin, Allantoin, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Ceramide NG, PEG-10 Phytosterol, Sodium PCA, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Oligopeptide-68, Sodium Oleate, Linalool, Citral, Sodium Carbonate, Limonene, Citronellol, Geraniol, Tocopherol, Palmitoyl Hexapeptide-12, Farnesol, Mica, Titanium Dioxide, Iron Oxides.
Package Label.Principal Display Panel
61354-050-01 (Art Asp00019 Page 1)
10ml, 61354-050-02
61354-050-02 (Art Asp00107)
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