The Green Beaver Kids Sunscreen SPF 40

THE GREEN BEAVER COMPANY SPF 40 KIDS SUNSCREEN- sunscreen lotion lotion
The Green Beaver Company

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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THE GREEN BEAVER COMPANY SPF 40 KIDS SUNSCREEN
sunscreen lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76098-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CEROTIC ACID (UNII: D42CQN6P36)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SQUALENE (UNII: 7QWM220FJH)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM BETA-SITOSTERYL SULFATE (UNII: I289C8TPSV)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
KARUM SEED OIL (UNII: 62160PU6FJ)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76098-002-01	94 g in 1 TUBE; Type 0: Not a Combination Product	01/26/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/26/2018

Labeler - The Green Beaver Company (243807018)

Registrant - Regulatory Matters Consulting (080711165)