Label: MAYA SOLAR NATURAL SUNSCREEN 45 SPF- sunscreen cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42069-001-01 - Packager: Batab Health Care S.a. de C.v.
- 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 July 24, 2015
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- Front Tag Product 42069-001
- Back Tag Product 42069-001
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INGREDIENTS AND APPEARANCE
MAYA SOLAR NATURAL SUNSCREEN 45 SPF
sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42069-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) 21 g in 100 g SUNFLOWER OIL (UNII: 3W1JG795YI) 20 g in 100 g ALCOHOL (UNII: 3K9958V90M) 10 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) 5 g in 100 g PALM OIL (UNII: 5QUO05548Z) 3 g in 100 g GRAPEFRUIT SEED OIL (UNII: 598D944HOL) 0.5 g in 100 g LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.1 g in 100 g YELLOW WAX (UNII: 2ZA36H0S2V) 0.1 g in 100 g PALM KERNEL OIL (UNII: B0S90M0233) 0.1 g in 100 g BIXA ORELLANA LEAF (UNII: KQ341J3HXI) 0.125 g in 100 g CNIDOSCOLUS CHAYAMANSA LEAF (UNII: EE92I958T0) 0.25 g in 100 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.1 g in 100 g WATER (UNII: 059QF0KO0R) 29.325 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42069-001-01 150 g in 1 TUBE; 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 02/25/2005 Labeler - Batab Health Care S.a. de C.v. (813153764) Establishment Name Address ID/FEI Business Operations Batab Health Care S.a. de C.v. 813153764 manufacture(42069-001)
