COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50

Main information

  • Trade name:
  • COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50- avobenzone,homosalate,octisalate,octocrylene,oxybenzone spray
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Sunscreen Uses ■ helps prevent sunburn Flammable : Do not use near heat, flame, or while smoking 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:
  • 11523-7406-1
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50-

avobenzone,homosalate,octisalate,octocrylene,oxybenzone spray

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.

----------

Defend & Care Ultra Hydrate Spray SPF 50

Drug Facts

Drug Facts

Active ingredients

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 9%, Oxybenzone 2%

Purpos e

Purpose

Sunscreen

Us es

Uses

■ helps prevent sunburn

Warnings

Warnings

For external use only

Do not use

Flammable: Do not use near heat, flame, or while smoking

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 if

Stop use and ask 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

■ shake well before use

■ apply liberally 15 minutes before sun exposure and rub into skin

■ do not spray directly on face. Spray 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

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredients SD alcohol 40-B (40.3% v/v), isobutane, isohexadecane, isododecane,

dimethicone, VA /butyl maleate/isobornyl acrylate copolymer, C13-15 alkane, tocopherol (vitamin E),

ascorbyl palmitate, fragrance

Questions? 1-866-288-3330

Coppertone®

Sunscreen Spray

Defend

& Care ™

Ultra

Hydrate 50

With Nourishing Antioxidants

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50

avobenzone,homosalate,octisalate,octocrylene,oxybenzone spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-740 6

Bayer HealthCare LLC.

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

AVOBENZONE

21.9 mg in 1 g

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

OCTISALATE

32.8 mg in 1 g

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

OCTOCRYLENE

6 5.7 mg in 1 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

14.6 mg in 1 g

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

HOMOSALATE

73.0 8 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

C13 -15 ALKANE (UNII: 114P5I43UJ)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

ISO BUTANE (UNII: BXR49 TP6 11)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

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 6 -1

142 g in 1 CAN; 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

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 10/2017