COPPERTONE KIDS SPF 50- octinoxate, octisalate, and zinc oxide 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

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

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

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

Inactive Ingredients

Water, Propylene Glycol, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Extract, Ethylhexyl Palmitate, Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Chloride

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

New Look

Coppertone ®

SUNSCREEN LOTION

kids tear free

Mineral-Based

Formula 50

Water Resistant

(80 Minutes)
Broad Spectrum

SPF 50

#1 PEDIATRICIAN
RECOMMENDED BRAND

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS  SPF 50
octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	85.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	56.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	164.72 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: 11523-7301-1	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	08/01/2020
2	NDC: 11523-7301-2	177 mL in 1 BOTTLE, PLASTIC; 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 not final	part352	05/21/1999	08/01/2020

Labeler - Bayer Healthcare LLC. (112117283)