MAYA SOLAR NATURAL SUNSCREEN 45 SPF- sunscreen cream
Batab Health Care S.a. de C.v.

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.

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MAYA SOLAR NATURAL SUNSCREEN 45 SPF
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42069-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42069-001-01	150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/25/2005

Labeler - Batab Health Care S.a. de C.v. (813153764)

Name	Address	ID/FEI	Business Operations
Establishment
Batab Health Care S.a. de C.v.		813153764	manufacture(42069-001)

Front Tag Product 42069-001

Back Tag Product 42069-001