ANTIOXIDANT SUNSCREEN SPF 40- octinoxate and zinc oxide lotion 
Topiderm, Inc.

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Vit C Antioxidant Sunscreen SPF 40

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 7.0%Sunscreen

Uses

Warnings

For external use only.

When using this product keep out of eyes, rinse with water to remove.

Stop use if signs of irritation or rash appear.If irritation or rash persists consult a doctor.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Inactive ingredients

Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Ceresin, Chitosan, Cyclomethicone, Diazolidinyl Urea, Disodium EDTA, Laureth-7, Lauryl PEG/PPG-18/18 Methicone, Methylparaben, Phospholipids, Polyacrylamide, Propyl Gallate, Propylene Glycol, Propylparaben, Purified Water, Retinyl Palmitate, Sodium Chloride, Superdioxide Dismutase, Tocopheryl Acetate, Ubiquinone (Co Q-10).

PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label

CITRIX®

VITAMIN C
ANTIOXIDANT SUNSCREEN
BROAD SPECTRUM SPF 40

UVA & UVB Protection
Micronized Zinc Oxide
Water Resistant (80 minutes)

POLYMER MATRIX TECHNOLOGY

Net 3.5 fl. oz. (105 ml)
Topix Pharmaceuticals, Inc. | N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label
ANTIOXIDANT SUNSCREEN SPF 40 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-829
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CERESIN (UNII: Q1LS2UJO3A)  
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LAURETH-7 (UNII: Z95S6G8201)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-829-03105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2000
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02007/28/2000
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-829)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals, Inc.117745066PACK(51326-829)

Revised: 11/2019
Document Id: 1e23a07e-f101-477a-98ab-51df88e50464
Set id: 2686378c-8827-47fb-b3ed-07438bd4e9e2
Version: 6
Effective Time: 20191113
 
Topiderm, Inc.