COPPERTONE KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Coppertone kids by

Drug Labeling and Warnings

Coppertone kids 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 ingredients

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 5%, Oxybenzone 6%

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 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 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, Styrene/Acrylates Copolymer, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Triethanolamine, Chlorphenesin, Fragrance, Oleth-3, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Disodium EDTA

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Coppertone ®

SUNSCREEN LOTION

kids

Broad

Spectrum

SPF

50

#1 PEDIATRICIAN

RECOMMENDED BRAND

Won't Run Into

Eyes And Sting

Water Resistant

(80 minutes)

50

3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS  SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	131.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TROLAMINE (UNII: 9O3K93S3TK)
CHLORPHENESIN (UNII: I670DAL4SZ)
OLETH-3 (UNII: BQZ26235UC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM (UNII: 7FLD91C86K)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7371-1	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/1999	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/21/1999	08/01/2020

Labeler - Bayer Healthcare LLC (112117283)