COPPERTONE PURE AND SIMPLE FACE SPF 50- zinc oxide lotion

Coppertone Pure and Simple Face SPF 50 by

Drug Labeling and Warnings

Coppertone Pure and Simple Face SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Zinc Oxide 24.08%

PURPOSE

Purpose

Sunscreen

Uses

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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

■ shake well before each use

■ apply liberally 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Other information

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylysilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, sodium chloride

QUESTIONS

Questions? 1-866-288-3330

Package label 2 oz.

New
Coppertone®
SUNSCREEN LOTION
Pure &
Simple
+ 100% natural botanicals*
Tear Free
FOR FACE 50

Won't Clog Pores

Zinc Oxide Protection

No PABA, Parabens, Phthalates,
Fragrances, Dyes, Oxybenzone
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE PURE AND SIMPLE FACE SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7459
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250.19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
YELLOW WAX (UNII: 2ZA36H0S2V)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Product Characteristics
Color	yellow (Off-white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7459-1	59 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2018	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)