SUN CARE FOR FACE- octinoxate avobenzone zinc oxide octocrylene emulsion

Sun Care by

Drug Labeling and Warnings

Sun Care by is a Otc medication manufactured, distributed, or labeled by Zenith Medicosm SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%

Octocrylene 10%

Avobenzone 3%

Zinc Oxide 24%

Description

SUN CARE CREAM FOR FACE

SPF 25

MEDIUM 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN CARE  FOR FACE
octinoxate avobenzone zinc oxide octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
SODIUM DESOXYCHOLATE (UNII: 436LS6U35Y)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
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)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
UREA (UNII: 8W8T17847W)
ALCOHOL (UNII: 3K9958V90M)
PEG-32 STEARATE (UNII: 33GX5WQC0M)
ALLANTOIN (UNII: 344S277G0Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-121-01	60 mL in 1 TUBE

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

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

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