Label: HA PHYSICAL TINT SPF 44- zinc oxide, titanium dioxide cream
- NDC Code(s): 72957-006-01
- Packager: Private Label Skin Care
- This is a repackaged label.
- Source NDC Code(s): 39765-022
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 20, 2022
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- Drug Facts
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- WARNINGS
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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.
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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
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INGREDIENTS AND APPEARANCE
HA PHYSICAL TINT SPF 44
zinc oxide, titanium dioxide creamProduct 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)
