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Distributed by Cremo Company LLC, Laguna Beach, CA 92651
(800) 853-1762 © 2019 Cremo Co. Not tested on Animals.
Cremo Sunscreen
FDA Label NDC 71825-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cremo Company for the product Cremo Sunscreen (NDC 71825-102). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Avobenzone 3%
Octisalate 5%
Octocrylene 7.5%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use on broken or damaged skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- Sun Protections 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Storage And Handling
Other information
Protect this product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients Acrylamide/Sodium Acroylyldimethyl Taurate Copolymer, Aloe Vera Juice, Water (Aqua),Green Tea Extract, Carbomer, Cetyl Alcohol, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexylglycerin, Sunflower Oil, Isohexadecane, Phenoxyethanol, Polysorbate 20, Polysorbate-80, Propylene Glycol, Pomegranate Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine
Package Label.Principal Display Panel
Cremo®
Astonishingly Superior®
FACE LOTION WITH SUNSCREEN
PREVENTATIVE FORMULA
HYDRATES & NOURISHES WHILE PROTECTING SKIN FROM THE ELEMENTS
BROAD SPECTRUM SPF 20
MOISTURIZER + SUN PROTECTION
Essential skincare
2 FL OZ (59 mL)
111319_cremo_moisturizer (111319 Cremo Moisturizer)
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