OTC Medication Information: Coppertone Every Tone Sunscreen SPF 50

COPPERTONE EVERY TONE SUNSCREEN SPF 50- avobenzone, octocrylene, homosalate and octisalate lotion
Beiersdorf Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

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

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

■ shake well before 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

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Questions?

1-866-288-3330

Coppertone ®

Sunscreen Lotion

Advised by Dermatologists for Skin of Color

Every Tone

Blends Clear On All Skin Tones

50

No White Resdiue

Lightweight & Won’t Clog Pores

with nourishing Vitamin E

Free of Oxybenzone, Octinoxate, PABA & Phthalates

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Every Tone
(click image for full-size original)
COPPERTONE EVERY TONE SUNSCREEN SPF 50
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-1093
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 9 g in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 9 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 4.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S)
DIISOPROPYL ADIPATE
DIMETHICONE
POLYAMIDE-8 (4500 MW)
ISODODECANE
TOCOPHEROL
ARACHIDYL GLUCOSIDE
ALCOHOL
GLYCERETH-26
ETHYLHEXYL METHOXYCRYLENE
BUTYLENE GLYCOL
XANTHAN GUM
DOCOSANOL
SODIUM ASCORBYL PHOSPHATE
WATER
BUTYLOCTYL SALICYLATE
DIETHYLHEXYL CARBONATE
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
DISODIUM EDTA-COPPER
GLYCERIN
1,2-HEXANEDIOL
HYDROXYACETOPHENONE
ARACHIDYL ALCOHOL
Product Characteristics
Color white (White to Off-White) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66800-1093-7 207 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2023
Labeler — Beiersdorf Inc (001177906)

Revised: 02/2023 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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