COPPERTONE 5X UV PROTECT FACE SUNSCREEN- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

Coppertone 5X UV Protect Face Sunscreen by

Drug Labeling and Warnings

Coppertone 5X UV Protect Face Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ 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

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

water, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, diethylhexyl syringylidenemalonate, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone Sunscreen Lotion

UV Protect

Face

SPF 50+ PA+++

5X

UVA/UVB Protection

Anti Photo-aging

Light Weight

Oil Free

Hydrates Skin

Water Resistant (80 Minutes)

Broad Spectrum SPF 50+

INGREDIENTS AND APPEARANCE

COPPERTONE 5X UV PROTECT FACE SUNSCREEN 
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-0067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-0067-2	74 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/01/2023

Labeler - Beiersdorf Inc (001177906)