Label: SUNSCREEN SPF 30- avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-887-06 - Packager: Top Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 26, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Actives
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
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Directions
- apply liberally 15 minutes before sun exposure
- Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours
- Sun Protection 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 of 15 or higher and other sun protection measure 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
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidemaionate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oieth-3, Polyamide-8, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30
avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-887 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) BENZYL ALCOHOL (UNII: LKG8494WBH) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHLORPHENESIN (UNII: I670DAL4SZ) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYL PALMITATE (UNII: 2865993309) OLETH-3 (UNII: BQZ26235UC) NEOPENTYL GLYCOL (UNII: QI80HXD6S5) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SORBITOL (UNII: 506T60A25R) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-887-06 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/23/2016 Labeler - Top Care (006935977) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(36800-887) , label(36800-887)
