Label: SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone gel
- NDC Code(s): 61354-047-01, 61354-047-02, 61354-047-03, 61354-047-04
- Packager: Oxygen Development, LLC
- 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 February 3, 2023
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- Active ingredient
- Uses
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.
Sun protection meassures: Spending time in the sun increasses 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, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.
- Inactive ingredients
- Package
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INGREDIENTS AND APPEARANCE
SUNSCREEN
homosalate, octocrylene, octisalate, avobenzone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mg in 100 mg AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 100 mg Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) 49.8 mg in 100 mg CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) 2 mg in 100 mg DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 2.85 mg in 100 mg VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) 1.25 mg in 100 mg BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 2 mg in 100 mg DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 12.46 mg in 100 mg ALUMINUM HEXAFLUOROSILICATE NONAHYDRATE (UNII: L5630XRC87) 1.5 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-047-04 1 in 1 PACKAGE 02/14/2022 1 NDC:61354-047-03 1 in 1 CARTON 1 NDC:61354-047-02 1 in 1 PACKAGE 1 NDC:61354-047-01 100 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/14/2022 Labeler - Oxygen Development, LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development, LLC 137098492 manufacture(61354-047)
