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 ingredient

Zinc Oxide 10%

Titanium Dioxide 5.5%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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

Directions

Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. 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 SPF value of 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 doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

SPL UNCLASSIFIED SECTION

brand MD

Broad Spectrum Sunscreen
Water Resistant (40 Minutes)

Titanium Dioxide 10%
Zinc Oxide 5.5%
Hyaluronic Acid

MEDICAL GRADE

SHIELD

RECOMMENDED FOR
COMBO  OILY
DRY       SENSITIVE
NORMAL

GREEN LEAF PROGRAM

NOT TESTED ON ANIMALS

Distributed by:
brandMD®
Canoga Park, CA 91304
(818) 534-3180
www.brandMD.com

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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
METHICONE (20 CST) (UNII: 6777U11MKT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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 Drug	M020	06/01/2020

Labeler - Private Label Skin Care (116996962)

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