COPPERTONE PURE AND SIMPLE BABY SPF 50- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Bayer HealthCare LLC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
11523-7441-1, 11523-7441-2

COPPERTONE PURE AND SIMPLE BABY SPF 50- zinc oxide lotion

Bayer HealthCare LLC.

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.

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Coppertone Pure & Simple Baby Lotion SPF 50 UI 1613993

Drug Facts

Active ingredients

Zinc Oxide 24.08%

Purpose

Sunscreen

Us es

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

Directions

■ shake well before each 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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl

isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-

octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene,

polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred

lotus (nelumbo nucifera) extract*, triethoxycaprylysilane, beeswax, hydroxyacetophenone, PEG-12

dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, sodium chloride

Questions? 1-866-288-3330

Coppertone®

SUNSCREEN LOTION

Pure &

Simple

baby

+100% natural botanicals*

Tear Free

Hypoallergenic & Gentle 50

# 1 Pediatrician

Recommended Brand

Zinc Oxide Protection

No PABA, Parabens, Phthalates,

Fragrances, Dyes, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

COPPERTONE PURE AND SIMPLE BABY SPF 50

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-7441

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

250 .19 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

MACRO CYSTIS PYRIFERA (UNII: K31S3OG5C4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

CAMELLIA SINENSIS SEED O IL (UNII: O5R6 DK2M9 K)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

HYDRO XYACETO PHENO NE (UNII: G1L3HT4CMH)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

WHITE WAX (UNII: 7G1J5DA9 7F)

BIS-O CTYLDO DECYL DIMER DILINO LEATE/PRO PANEDIO L CO PO LYMER (UNII: TY3J9 8 ZR7R)

ETHYLHEXYL ISO NO NANO ATE (UNII: I6 KB4GE3K4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

Bayer HealthCare LLC.

ETHYLHEXYL METHO XYCRYLENE (UNII: S3KFG6 Q5X8 )

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 1.5) (UNII: V2W71V8 T0 X)

NELUMBO NUCIFERA FLO WER O IL (UNII: P6 58 Q19 EG2)

PEG-12 DIMETHICO NE/PPG-2 0 CRO SSPO LYMER (UNII: 9 6 5K72OQXO)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

Product Characteristics

Color

yello w (Off white to pale yello w)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:11523-7441-

59 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 19

0 8 /0 1/20 21

2

NDC:11523-7441-

177 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 19

0 8 /0 1/20 21

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 2/0 1/20 19

0 8 /0 1/20 21

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 8/2019

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