SHEER DEFENSE TINTED BROAD SPECTRUM SUNSCREEN SPF 50- zinc oxide, octinoxate cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 12%
Octinoxate 7.5%

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 80 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, Isododecane, Dimethicone, Propanediol, Polyglyceryl-6 Polyricinoleate, Niacinamide, Polymethylsilsesquioxane/ Trimethylsiloxysilicate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, C12-15 Alkyl Benzoate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Polyhydroxystearic Acid, 1,2-Hexanediol, Shea (Butyrospermum Parkii) Butter, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Glycerin, Sodium Hyaluronate, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Caprylyl/Capryl Glucoside, Triethoxycaprylylsilane, Castor Oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Decyl Glucoside, Sodium Cocoyl Glutamate, Glyceryl Caprylate, Citric Acid, Polyglyceryl-6 Oleate, Polygonum Aviculare Extract, Sodium Surfactin, Titanium Dioxide CI 77891, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499)

SPL UNCLASSIFIED SECTION

brand MD

Water Resistant (80 Minutes)

Blue Light Protection

MEDICAL GRADE

SHIELD

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

GREEN LEAF PROGRAM

NOT TESTED ON ANIMALS

RECOMMENDED FOR
ALL SKIN TYPES

Packaging

INGREDIENTS AND APPEARANCE

SHEER DEFENSE TINTED BROAD SPECTRUM SUNSCREEN SPF 50 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72957-015(NDC:39765-062)
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)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
PHENYLSILANETRIOL (UNII: DNR46JQ8BT)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SHEA BUTTER (UNII: K49155WL9Y)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CASTOR OIL/IPDI COPOLYMER (UNII: GSA2TXZ34G)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYGLYCERYL-6 OLEATE (UNII: G4AYJ54K59)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM SURFACTIN (UNII: HBD7CC5UGF)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 72957-015-01	57 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/20/2026

Labeler - Private Label Skin Care (116996962)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Skin Care		116996962	relabel(72957-015)