Label: SEA AND SKI SPF 70- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73440-2081-1 - Packager: Cross-Brands Contract FIlling
- 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 19, 2021
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INGREDIENTS AND APPEARANCE
SEA AND SKI SPF 70
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73440-2081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 6.81 g in 227 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 34.05 g in 227 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 18.16 g in 227 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 11.35 g in 227 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 17.03 g in 227 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 103.73 g in 227 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73440-2081-1 227 g in 1 TUBE; Type 0: Not a Combination Product 01/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/04/2017 Labeler - Cross-Brands Contract FIlling (117871824) Establishment Name Address ID/FEI Business Operations Cross Brands Contract Filling 117871824 label(73440-2081) , manufacture(73440-2081) , pack(73440-2081)