Label: CREMO SUNSCREEN- avobenzone, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71825-102-01 - Packager: Cremo company
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 9, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREMO SUNSCREEN
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71825-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GREEN TEA LEAF (UNII: W2ZU1RY8B0) WATER (UNII: 059QF0KO0R) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE (UNII: 92RU3N3Y1O) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 4 (UNII: CZ227117JE) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POMEGRANATE (UNII: 56687D1Z4D) SUNFLOWER OIL (UNII: 3W1JG795YI) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 940 (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71825-102-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2020 Labeler - Cremo company (078708508)
