SUN CARE FOR FACE- octinoxate avobenzone zinc oxide octocrylene cream
Zenith Medicosm SL

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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Drug Facts

Active Ingredient

Octinoxate 7.5%

Octocrylene 10%

Avobenzone 3%

Zinc Oxide 24%

Description

SUN CARE CREAM FOR FACE

SPF 50

HIGH PROTECTION

UVA - UVB - WATER RESISTANT

Exclusive emulsion with a a new protection system against UVA and UVB rays and active ingredients responsible for cell longevity (marine DNA, collagen, sirtuin activators).

60ml. 2Fl.Oz.

Warning

TOPICAL USE

Instructions for use

Apply half hour before exposure to the sun and repeat as often as necessary.

SUN CARE FOR FACE
octinoxate avobenzone zinc oxide octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42248-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 mL in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 mL in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 mL in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 mL in 60 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM DESOXYCHOLATE (UNII: 436LS6U35Y)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900 KD) (UNII: B70CUU14M9)
WATER (UNII: 059QF0KO0R)
TRICAPRYLIN (UNII: 6P92858988)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)
1-ETHYL-2-PYRROLECARBOXALDEHYDE (UNII: 51J1CE738Y)
RICE GERM (UNII: 7N2B70SFEZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42248-120-01	60 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/15/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Name	Address	ID/FEI	Business Operations
Establishment
Zenith Medicosm SL		464239694	manufacture