Label: DERMA SOLEIL DRY SPORTS 30 SPF- octocrylene,octyl methoxycinnamate,octyl salicylate,oxybenzone aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69711-910-01 - Packager: Derma Soleil
- 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 February 21, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
- WARNINGS
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INACTIVE INGREDIENT
Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
• Apply liberally 15 minutes before sun exposure • Reapply: • after 40 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 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: ask a doctor - KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMA SOLEIL DRY SPORTS 30 SPF
octocrylene,octyl methoxycinnamate,octyl salicylate,oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69711-910 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SODIUM LEVULINATE (UNII: VK44E1MQU8) SODIUM ANISATE (UNII: F9WFJ28MV9) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) ALOE VERA LEAF (UNII: ZY81Z83H0X) JOJOBA OIL (UNII: 724GKU717M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) AVOCADO OIL (UNII: 6VNO72PFC1) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) GRAPE SEED OIL (UNII: 930MLC8XGG) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69711-910-01 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/21/2020 Labeler - Derma Soleil (079767886) Establishment Name Address ID/FEI Business Operations Deserving Health International Corp. 202617023 manufacture(69711-910)
