PURELY PHYSICAL SPF 47- zinc oxide, titanium dioxide 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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Purely Physical SPF 47

Drug Facts

Active Ingredients

Zinc Oxide 10%

Titanium Dioxide 5.5%

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.

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

Directions • Apply on a clean, dry face in the morning avoiding delicate eye area. Apply 15 minutes before sun exposure. May be used daily. Consult physician before use. Reapply after prolonged exposure, physical activity, perspiration or contact with water.

Precautions • 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 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.

Inactive Ingredients: Water/Aqua/Eau, Caprylyl Methicone, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Alumina, Sodium Chloride, Methicone, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, 1,2-Hexanediol, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propylene Carbonate, Disodium EDTA, Ethylhexylglycerin, Triethoxycaprylylsilane, Phenoxyethanol

brandMD®

SKIN CARE

SUN DEFENSE

medical grade

Broad-spectrum coverage against UVA and UVB

Chemical-free active ingredients

Water resistant (80 minutes)

RECOMMENDED SKIN TYPES

A - ACNE

C - COMBO

D - DRY

N - NORMAL

O - OILY

S- SENSITIVE

brandMD®
Chatsworth, CA 91311
www.brandMD.com
Toll Free: (877) 252-7546

Packaging

4511

PURELY PHYSICAL SPF 47 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72957-005(NDC:39765-020)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72957-005-01139 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2020
Labeler - Private Label Skin Care (116996962)
Establishment
NameAddressID/FEIBusiness Operations
Private Label Skin Care116996962relabel(72957-005)

Revised: 1/2022
Document Id: edfa75dd-329d-43c9-bfd6-ee42fba7e418
Set id: 6234663f-ee89-4d80-8493-225409c27564
Version: 3
Effective Time: 20220120
 
Private Label Skin Care