COPPERTONE WET AND CLEAR KIDS SPF 50 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Coppertone Wet and Clear Kids by

Drug Labeling and Warnings

Coppertone Wet and Clear 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 10%, Octisalate 4.5%, Octocrylene 9%, Oxybenzone 5%

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

Flammable

Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• 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.

Directions

• apply liberally 15 minutes before sun exposure
• do not spray directly on face. Spray 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

• may stain or damage some fabrics or surfaces
• avoid long term storage above 40°C (104°F)
• protect this product from excessive heat and direct sun

Inactive Ingredients

SD Alcohol 40-B (49.5% V/V), C12-15 Alkyl Benzoate, Octyldodecyl Citrate Crosspolymer, Isohexadecane, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Tocopherol (Vitamin E), Ascorbyl Palmitate, C13-15 Alkane, Fragrance

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COPPERTONE WET AND CLEAR KIDS  SPF 50 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.73 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	89.11 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	44.56 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
C13-15 ALKANE (UNII: 114P5I43UJ)

Product Characteristics
Color	yellow (Clear, yellow to dark)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7355-2	177 mL in 1 CAN; Type 0: Not a Combination Product	03/15/2012	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2012	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)