Label: BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15- avobenzone, ensulizole, octinoxate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59582-015-01 - Packager: EBPD LLC
- 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 August 23, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours
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Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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.
- Other information
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Inactive ingredients
WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, C12-15 ALKYL BENZOATE, CETEARYL OLIVATE, PENTAERYTHRITYL DISTEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, DIMETHICONE, PVP/HEXADECENE COPOLYMER, ORYZA SATIVA (RICE) BRAN EXTRACT, HYDROLYZED RICE PROTEIN, PANTHENOL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EUTERPA OLERACEA FRUIT EXTRACT, XANTHAN GUM, CARBOMER, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, SODIUM HYALURONATE, DIAZOLIDINYL UREA, SODIUM HYDROXIDE, FRAGRANCE, BHT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, CITRONELLOL, BUTYLPHENYL METHYLPROPIONAL, LINALOOL, HEXYL CINNAMAL, LIMONENE, ALPHA-ISOMETHYL IONONE, EUGENOL.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
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INGREDIENTS AND APPEARANCE
BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15
avobenzone, ensulizole, octinoxate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59582-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 20 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Tricaprylin (UNII: 6P92858988) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Cetearyl Olivate (UNII: 58B69Q84JO) Pentaerythritol (UNII: SU420W1S6N) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Sorbitan Olivate (UNII: MDL271E3GR) Sheanut Oil (UNII: O88E196QRF) Dimethicone (UNII: 92RU3N3Y1O) Hexadecyl Povidone (4 Hexadecyl Branches/Repeat) (UNII: AG75W62QYU) Rice Bran (UNII: R60QEP13IC) Panthenol (UNII: WV9CM0O67Z) Olea Europaea Leaf (UNII: MJ95C3OH47) Acai (UNII: 46AM2VJ0AW) Xanthan Gum (UNII: TTV12P4NEE) Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208) Ethylhexyl Palmitate (UNII: 2865993309) Silica Dimethyl Silylate (UNII: EU2PSP0G0W) Butylene Glycol (UNII: 3XUS85K0RA) Hyaluronate Sodium (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59582-015-01 1 in 1 CARTON 1 100 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/15/2013 Labeler - EBPD LLC (077477227) Establishment Name Address ID/FEI Business Operations ORLANE S.A. 578687469 MANUFACTURE(59582-015)
