SHEER DEFENSE TINTED SPF 46- zinc oxide, octinoxate cream 
Private Label Skin Care

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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Sheer Defense Tinted SPF 46

Drug Facts

Active ingredient

Zinc Oxide 12%

Octinoxate 7.5%

Purpose

Sunscreen

Use Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

PrecautionsSpending 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions • Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician.

Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.

Inactive Ingredients Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Polygonum Aviculare Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxides, Phenoxyethanol

SUN DEFENSE

medical grade

Fast-absorbing SPF featuring a high level of niacinamide

Universal tint matching most skin types

brandMD®

Chatsworth, CA 91311

www.brandMD.com

Toll Free: (877) 252-7546

Packaging

TintSPF

SHEER DEFENSE TINTED SPF 46 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72957-002(NDC:39765-023)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72957-002-0157 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/2020
Labeler - Private Label Skin Care (116996962)
Establishment
NameAddressID/FEIBusiness Operations
Private Label Skin Care116996962relabel(72957-002)

Revised: 1/2022
Document Id: e5e73204-7d18-4032-a3ca-6b671759ee3e
Set id: 017265e9-31e6-43ce-9432-cb88f471c496
Version: 3
Effective Time: 20220120
 
Private Label Skin Care