PURELY PHYSICAL SPF 47- zinc oxide, titanium dioxide cream

Purely Physical SPF 47 by

Drug Labeling and Warnings

Purely Physical SPF 47 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 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.

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

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

INGREDIENTS AND APPEARANCE

PURELY PHYSICAL SPF 47 
zinc oxide, titanium dioxide cream

Product 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)