COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50

Main information

  • Trade name:
  • COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, zinc oxide lotion
  • Composition:
  • OCTINOXATE 79.5 mg in 1 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, zinc oxide lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Sunscreen Use ■ helps prevent sunburn Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 11523-7413-2, 11523-7413-3
  • Last update:
  • 21-06-2019

Summary of Product characteristics: dosage, interactions, side effects

COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, 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 Defend and Care Clear Zinc SPF 50

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7%

Purpose

Sunscreen

Us e

Use

■ helps prevent sunburn

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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients water, dicaprylyl ether, glycerin, polyester-27, styrene/acrylates copolymer,

trilaureth-4 phosphate, cetearyl alcohol, beeswax, dimethicone, ammonium acryloyldimethyltaurate/vp

copolymer, benzyl alcohol, glyceryl stearate, triethoxycaprylylsilane, chlorphenesin, disodium EDTA

Questions? 1-866-288-3330

Package Display Panel

New

Coppertone®

Sunscreen Lotion

Defend

& Care™

Clear

Zinc 50

Advanced

Invisible Protection

Water Resistant (80 minutes)

Broad Spectrum SPF 50

COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50

octinoxate, octisalate, zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-7413

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTINOXATE

79 .5 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

47.7 mg in 1 mL

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

ZINC OXIDE

10 2.8 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

STYRENE/ACRYLAMIDE CO PO LYMER ( MW 50 0 0 0 0 ) (UNII: 5Z4DPO246 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

WATER (UNII: 0 59 QF0 KO0 R)

DICAPRYLYL ETHER (UNII: 77JZM5516 Z)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRILAURETH-4 PHO SPHATE (UNII: M9 6 W2OLL2V)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

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:11523-7413-2

8 8 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 17

2

NDC:11523-7413-3

177 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

11/0 1/20 17

Bayer HealthCare LLC.

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 10/2017