Label: PURELY PHYSICAL SPF 47- zinc oxide, titanium dioxide cream
- NDC Code(s): 72957-005-01
- Packager: Private Label Skin Care
- This is a repackaged label.
- Source NDC Code(s): 39765-020
- 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
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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.
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INACTIVE INGREDIENT
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
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SPL UNCLASSIFIED SECTION
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
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INGREDIENTS AND APPEARANCE
PURELY PHYSICAL SPF 47
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72957-005(NDC:39765-020) 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72957-005-01 139 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(72957-005)
