COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 30

Main information

  • Trade name:
  • COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
    United States
  • Language:
  • English

Therapeutic information

  • 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 Do not use on damaged or broken skin Stop use and as a doctor if rash occurs

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 11523-7407-1
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 30- avobenzone,

homosalate, octisalate, octocrylene 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 & Care Ultra Hydrate Whipped Sunscreen SPF 30

Drug Facts

Drug Facts

Active ingredients

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%,

Octisalate 4.5%, Octocrylene 8%

Purpos e

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

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using this product

When using this product

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

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be

harmful or fatal.

■ do not puncture or incinerate. Contents under pressure. Do not store at

temperatures above 120°F.

Stop use and ask a doctor

Stop use and as a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control

Center right away.

Directions

Directions

■ apply liberally 15 minutes before sun exposure ■ do not dispense or apply directly on face. Dispense

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

Other information

■ protect this product from excessive heat and direct sun

■ avoid long term storage above 40°C (104°F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredients water, aluminum starch octenylsuccinate, behenyl alcohol, glycerin,

styrene/acrylates copolymer, dicaprylyl ether, nitrous oxide, microcrystalline cellulose, glyceryl

stearate, cetyl alcohol, benzyl alcohol, butylated PVP, palmitic acid, stearic acid, myristyl alcohol,

chlorphenesin, tocopherol (vitamin E), cellulose gum, lecithin, disodium EDTA, lauryl alcohol, sodium

ascorbyl phosphate, fragrance

Ques tions ?

Questions? 1-866-288-3330

Package label display

New Look

Coppertone®

Sunscreen

Defend

& Care™

Whipped

Ultra Hydrate 30

Helps leave skin

soft and smooth

Antioxidant

enriched

Water Resistant (80 Minutes)

Broad Spectrum SPF 30

COPPERTONE DEFEND AND CARE ULTRA HYDRATE WHIPPED SPF 30

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-740 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTISALATE

45.4 mg in 1 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 .3 mg in 1 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 1 mg in 1 g

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

OCTOCRYLENE

8 0 .8 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

DICAPRYLYL ETHER (UNII: 77JZM5516 Z)

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

PALMITIC ACID (UNII: 2V16 EO9 5H1)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

LAURYL ALCO HO L (UNII: 178 A9 6 NLP2)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

NITRO US O XIDE (UNII: K50 XQU10 29 )

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

MYRISTYL ALCO HO L (UNII: V420 34O9 PU)

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

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

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

Product Characteristics

Color

white (Off 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:11523-740 7-1

142 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 17

Bayer Healthcare LLC.

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

Labeler -

Bayer Healthcare LLC. (112117283)

Revised: 10/2017