Label: 5281 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion
- NDC Code(s): 76138-219-05
- Packager: Innovation Specialties
- This is a repackaged label.
- Source NDC Code(s): 70412-231
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 13, 2022
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- Drug Facts
- Active Ingredients
- Purpose:
- Uses
- Warnings
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Directions
•Apply liberally 15 minutes exposure. •reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours.
Sun Protection Measure.
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 15 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. - Inactive ingredients
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INGREDIENTS AND APPEARANCE
5281 SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76138-219(NDC:70412-231) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) LEVOMENOL (UNII: 24WE03BX2T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76138-219-05 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/10/2022 Labeler - Innovation Specialties (030837314) Establishment Name Address ID/FEI Business Operations Innovation Specialties 030837314 relabel(76138-219) , repack(76138-219)
