COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Coppertone Defend and Care Ultra Hydrate Whipped SPF 50 by

Drug Labeling and Warnings

Coppertone Defend and Care Ultra Hydrate Whipped 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

(To Deliver) Avobenzone 3%, Homosalate 9%, Octisalate 4.5%,

Octocrylene 9%

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.

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ do not puncture or incinerate. Contents under pressure. Do not store at

temperatures above 120°F.

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.

DOSAGE & ADMINISTRATION

Directions

■ apply liberally 15 minutes before sun exposure ■ do not dispense or apply directly on face. Dispense into hands and apply to face ■ use in well-ventilated areas ■ 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

■ avoid long term storage above 40°C (104°F)

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glycerin, dicaprylyl ether, nitrous oxide, microcrystalline cellulose, glyceryl stearate, cetyl alcohol, butylated PVP palmitic acid, stearic acid, hydroxacetophenone, myristyl alcohol, 1,2,-hexanediol, caprylyl glycol, tocopherol, cellulose gum, lecithin, fragrance, disodium EDTA, lauryl alcohol, sodium ascorbyl phosphate

QUESTIONS

Package label display

Improved

Formula
Coppertone®
SUNSCREEN
Defend & Care™
Whipped

Ultra Hydrate 50

Helps leave skin

soft and smooth

No Dyes, PABA, Oxybenzone
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
NET WT 5 OZ (142 g)

INGREDIENTS AND APPEARANCE

COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7456
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
NITROUS OXIDE (UNII: K50XQU1029)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURYL ALCOHOL (UNII: 178A96NLP2)
PALMITIC ACID (UNII: 2V16EO95H1)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	white (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: 11523-7456-1	142 g in 1 CAN; Type 0: Not a Combination Product	11/01/2017	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2017	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)