HA PHYSICAL TINT SPF 44- zinc oxide, titanium dioxide cream

HA Physical Tint SPF 44 by

Drug Labeling and Warnings

HA Physical Tint SPF 44 by is a Otc medication manufactured, distributed, or labeled by Private Label Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 10%

Titanium Dioxide 5.5%

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HA PHYSICAL TINT SPF 44 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72957-006(NDC:39765-022)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72957-006-01	59 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2020

Labeler - Private Label Skin Care (116996962)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Skin Care		116996962	relabel(72957-006)