CREAM- octinoxate, zinc oxide cream 
Oxygen Development LLC

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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Westmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep

active ingredients

Octinoxate 5%, Zinc Oxide 5%. Purpose: Sunscreen

purpose

sunscreen

uses

warnings

for external use only

do not use

on damage or broken skin

when using this product

keep out of eyes. rinse with water to remove

stop use

and ask a doctor if rash occurs

keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

Directions

sun protection measures

spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of at least 15 or higher and other sun protection measures including:

inactive ingredients

water (aqua/eau), Acetamidoethoxyethanol, Tridecyl Trimellitate, Octyldodecyl Neopentanoate, polysilicone-31, niacinimide, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Butylene Glycol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Isohexadecane, mica, Potassium Cetyl Phosphate, Peg-8 Dimethicone, PEG-100 Stearate, Glyceryl Stearate, glycerin, yeast extract, xanthan gum, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxycaprylylsilane, polysorbate 80, soy amino acids, Ethylhexylglycerin, Tetrahexyldecyl Ascorbate, Arnica Montana Flower Extract.

other information

protect this product from excessive heat and direct sun

package label - primary

61354-070-02_AW primary

package label - secondary

61354-070-06_AW secondary

CREAM 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 mg  in 100 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-070-061 in 1 CARTON02/22/202102/10/2023
1NDC:61354-070-0240 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/22/2021
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-070)

Revised: 2/2023
Document Id: f45d6b8d-6547-5e3d-e053-2a95a90a7b6b
Set id: bbf2abeb-fe02-8422-e053-2a95a90ac374
Version: 3
Effective Time: 20230210
 
Oxygen Development LLC