Label: COCO AND EVE TAN BOOSTING ANTI-AGING BODY OIL SPF 30 lotion
- NDC Code(s): 82931-005-15
- Packager: Supernova USA Inc.
- 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 June 5, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply generously an even layer all over body 20 minutes before sun exposure.
- Reapply frequently especially after swimming, sweating.
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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 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.
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INACTIVE INGREDIENT
Inactive Ingredients Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Coco-Caprylate, C13-15 Alkane, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Palmitate, Citrullus Lanatus (Watermelon) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, VP/Eicosene Copolymer, Psidium Guajava Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Tocopherol, Lecithin, Fragrance, Water.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COCO AND EVE TAN BOOSTING ANTI-AGING BODY OIL SPF 30
coco and eve tan boosting anti-aging body oil spf 30 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82931-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) C13-15 ALKANE (UNII: 114P5I43UJ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE (UNII: 4828G836N6) SUNFLOWER OIL (UNII: 3W1JG795YI) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) WATERMELON SEED OIL (UNII: L33J06UQTT) APRICOT KERNEL OIL (UNII: 54JB35T06A) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) TOCOPHEROL (UNII: R0ZB2556P8) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PINEAPPLE (UNII: 2A88ZO081O) GUAVA (UNII: 74O70D6VG0) COCOA (UNII: D9108TZ9KG) FRAGRANCE 13576 (UNII: 5EM498GW35) WATER (UNII: 059QF0KO0R) ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82931-005-15 1 in 1 CARTON 01/01/2024 1 150 mL in 1 BOTTLE, SPRAY; 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 01/01/2024 Labeler - Supernova USA Inc. (116909952)
