COPPERTONE PURE AND SIMPLE BABY SPF 50- octinoxate, octocrylene, zinc oxide stick

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

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Active ingredient:
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
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:
11523-7464-1

COPPERTONE PURE AND SIMPLE BABY SPF 50- octinoxate, octocrylene, zinc oxide stick

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 Stick SPF 50 UI 1613739

Drug Facts

Active ingredients

Octinoxate 7.5%, Octocrylene 10%, Zinc Oxide 15%

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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, lauryl

laurate, bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax

Questions? 1-866-288-3330

Package label 13.9 g

Coppertone®

SUNSCREEN STICK

Pure &

Simple Baby®

+ cocoa butter

Hypoallergenic & gentle

No PABA, Parabens,

Phthalates,Fragrances,

Dyes, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum

SPF 50

NET WT .49 OZ (13.9 g)

COPPERTONE PURE AND SIMPLE BABY SPF 50

octinoxate, octocrylene, zinc oxide stick

Bayer HealthCare LLC.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-746 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

10 0 mg in 1 g

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

ZINC OXIDE

150 mg in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

75 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CO CO A BUTTER (UNII: 512OYT1CRR)

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

YELLO W WAX (UNII: 2ZA36 H0 S2V)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CERESIN (UNII: Q1LS2UJO3A)

Product Characteristics

Color

white (o ff-white to light 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:11523-746 4-

13.9 g in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

11/0 1/20 18

0 9 /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

11/0 1/20 18

0 9 /0 1/20 21

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 12/2019

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