Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octcrylene 1%
Oxygenzone 5%
Purpose: Sunscreen
Moisturizer
FDA Label NDC 61354-035
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 61354-035). 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, do not use, when using, stop use, 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, decreases the risk of skin cancer and early skin aging caused by the sun
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 swallowed, get medical help or contact a poison control center right away
Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
Sun Protection Measures
Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF valuye of 15 or higher and other sun protection measures inclusing:
- limit time in the sun, specially from 10am - 2pm
- children under 6 months of age: ask a doctor
Other Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water, butylene glycol, glyceryl stearate, cetearyl alcohol, glycerin, potassium cetyl phosphate, stearic acid, oligopeptide-24, polysorbate 60, polyester-8, sclerotium gum, bisabolol, phenoxyethanol, dimethicone, sodium PCA, squalana, tocopheryl acetate, helianthus annus (sunflower) seed oil, persea gratissima (avocado) oil, allantoin, caprylyl glycol, phytosterols, chlorphenesin, olea europaea (olive) fruit oil, disodium EDTA, glycolipids, sodium hyaluronate, citrus aurantium dulcis (orange) oil, zingiber officinale (ginger) root extract, tocopherol, citral, linalool, limonene
Package Label - Primary
61354-030-04_aw (Art 20791)
Package Label - Secondary
61354-030-08_aw (Art 20793 Resized)
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