SHEER DEFENSE TINTED SPF 46- zinc oxide, octinoxate cream

Sheer Defense Tinted SPF 46 by

Drug Labeling and Warnings

Sheer Defense Tinted SPF 46 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 12%

Octinoxate 7.5%

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.

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.

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.

INACTIVE INGREDIENT

Inactive Ingredients Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Polygonum Aviculare Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxides, Phenoxyethanol

SPL UNCLASSIFIED SECTION

SUN DEFENSE

medical grade

Fast-absorbing SPF featuring a high level of niacinamide

Universal tint matching most skin types

brandMD®

Chatsworth, CA 91311

www.brandMD.com

Toll Free: (877) 252-7546

Packaging

INGREDIENTS AND APPEARANCE

SHEER DEFENSE TINTED SPF 46 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72957-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NIACINAMIDE (UNII: 25X51I8RD4)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72957-002-01	57 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/27/2020

Labeler - Private Label Skin Care (116996962)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Skin Care		116996962	relabel(72957-002)