HA PHYSICAL TINT SPF 44- 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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HA Physical Tint SPF 44

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 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.

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, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylyl Methicone, Iron Oxides, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Ethylhexylglycerin, Methicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Propylene Carbonate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Phenoxyethanol

brand MD®

SKIN CARE

SUN DEFENSE

medical grade

√ Lightweight, physical sunscreen contains a moisturizing base and a sheer, universal tint

√ Water resistant sunscreen (40 minutes)

brandMD®

Chatsworth, CA 91311

www.brandMD.com

Toll Free: (877) 252-7546

Packaging

4531

HA PHYSICAL TINT SPF 44 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72957-006(NDC:39765-022)
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)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72957-006-0159 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(72957-006)

Revised: 1/2022
Document Id: 91714b86-bc18-4e56-ba95-c3dd4a313a0b
Set id: a5e19d77-703e-41e0-9a02-19227dc6c819
Version: 3
Effective Time: 20220120
 
Private Label Skin Care