Label: ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS- zinc oxide, octinoxate, titanium dioxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-046-01 - Packager: SKINFOOD CO., LTD.
- 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 July 28, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredient:
WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, SORBITAN ISOSTEARATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, STEARIC ACID, BEESWAX, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER , DIMETHICONE, ALUMINA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, OZOKERITE, TALC, PROPYLENE CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/METHICONE COPOLYMER, HYALURONIC ACID, SILICA, ADENOSINE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499) - PURPOSE
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WARNINGS
Warning: Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.For external use only. Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs. Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- USE
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DIRECTIONS
DIRECTIONS:
Apply liberally 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 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. - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS
zinc oxide, octinoxate, titanium dioxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.70 g in 50 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.50 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.36 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.75 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-046-01 50 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2014 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture(76214-046)
