Label: BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-256-01 - Packager: Taylor James Ltd.
- 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 October 11, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating
• 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 your 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. -
INACTIVE INGREDIENT
Inactive Ingredients
Water, Isododecane, Glycerin, Trimethoxybenzylidene Pentanedione, Polyester-8, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Oryza Sativa (Rice) Bran Extract, Sucrose Stearate, Diisopropyl Sebacate, Hydroxyacetophenone, Isodecyl Neopentanoate, Lauryl Lactate, Sodium Polyacrylate Starch, Diethylhexyl Syringlidenemalonate, Sodium Stearoyl Glutamate, C18-38 Alkyl Hydroxystearoyl Stearate, Chlorphenesin, Ethylhexylglycerin, 1,2 Hexanediol, Caprylyl Glycol, Helianthus Annuus(Sunflower) Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Tocopherol, Romarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Hippophae Rhamnoides Seed Oil, Citrus Nobilis (Manadarin Orange) Peel Oil, Cymbopogon Schoenanthus Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-256 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 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 WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SORBITAN OLIVATE (UNII: MDL271E3GR) RICE BRAN (UNII: R60QEP13IC) SUCROSE STEARATE (UNII: 274KW0O50M) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) LAURYL LACTATE (UNII: G5SU0BFK7O) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) XANTHAN GUM (UNII: TTV12P4NEE) TOCOPHEROL (UNII: R0ZB2556P8) ROSEMARY (UNII: IJ67X351P9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) MANDARIN OIL (UNII: NJO720F72R) CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO) CARDAMOM OIL (UNII: JM0KJ091HZ) CLOVE LEAF OIL (UNII: VCA5491KVF) CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y) VANILLIN (UNII: CHI530446X) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVANDIN OIL (UNII: 9RES347CKG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-256-01 168 mL in 1 PACKAGE; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2020 Labeler - Taylor James Ltd. (033381850)
