Active Ingredients
Octinoxate 5%, Zinc Oxide 5%. Purpose: Sunscreen
Cream
FDA Label NDC 61354-070
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 Cream (NDC 61354-070). 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 measure (see directions), decreases the risk of skin cancer and early skin aging caused by 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
- Apply liberally 15 mins 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
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 of at least 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
Inactive Ingredients
water (aqua/eau), Acetamidoethoxyethanol, Tridecyl Trimellitate, Octyldodecyl Neopentanoate, polysilicone-31, niacinimide, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Butylene Glycol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Isohexadecane, mica, Potassium Cetyl Phosphate, Peg-8 Dimethicone, PEG-100 Stearate, Glyceryl Stearate, glycerin, yeast extract, xanthan gum, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxycaprylylsilane, polysorbate 80, soy amino acids, Ethylhexylglycerin, Tetrahexyldecyl Ascorbate, Arnica Montana Flower Extract.
Other Information
protect this product from excessive heat and direct sun
Primary Package
61354-070-01_aw (primary)
Secondary Packaging
61354-070-01_aw Secondary (Art Wb Sfc 2053a)
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