OTC Medication Information: Coppertone Complete Sunscreen SPF 45

COPPERTONE COMPLETE SUNSCREEN SPF 45- homosalate, octisalate, octocrylene and avobenzone lotion
Beiersdorf Inc

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 40 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

Questions?

1-866-288-3330

Inactive ingredients

water, alcohol denat., butyloctyl salicylate, silica, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, tapioca starch, behenyl alcohol, butylene glycol dicaprylate/dicaprate, C12-15 alkyl benzoate, cetearyl alcohol, copernicia cerifera (carnauba) wax, dibutyl adipate, tocopherol (Vitamin E), sodium ascorbyl phosphate, silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, sodium hyaluronate, cetyl alcohol

Coppertone® Sunscreen Lotion

Complete Face 45

Proven UVA/UVB Protection

+Hydrates

+Weightless & Oil Free

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (40 Minutes)

Broad Spectrum SPF 45

Complete Face 45
(click image for full-size original)
COPPERTONE COMPLETE SUNSCREEN SPF 45
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-8159
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
SODIUM ASCORBYL PHOSPHATE
XANTHAN GUM
HYDROXYACETOPHENONE
DISODIUM EDTA-COPPER
HYALURONATE SODIUM
CETOSTEARYL ALCOHOL
CARNAUBA WAX
DIBUTYL ADIPATE
TOCOPHEROL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
GLYCERIN
ALCOHOL
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER
GLYCERYL STEARATE SE
STARCH, TAPIOCA
SILICA DIMETHYL SILYLATE
WATER
BUTYLOCTYL SALICYLATE
TITANIUM DIOXIDE
BUTYLENE GLYCOL
ALKYL (C12-15) BENZOATE
CETYL ALCOHOL
DOCOSANOL
POLYGLYCERYL-6 STEARATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
DISODIUM STEAROYL GLUTAMATE
ETHYLHEXYLGLYCERYL BEHENATE
Product Characteristics
Color white ((white to off-white)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66800-8159-2 74 g in 1 TUBE None
2 NDC:66800-8159-5 14 g in 1 POUCH None
3 NDC:66800-8159-1 44 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 01/01/2023
Labeler — Beiersdorf Inc (001177906)

Revised: 02/2024 Beiersdorf Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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