COPPERTONE ULTRAGUARD  SPF 70 PLUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
MSD Consumer Care, Inc.

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® UltraGuard™
SPF 70+ Sunscreen Lotion

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics or surfaces

Inactive ingredients

Water, Butylene Glycol, Microcrystalline Cellulose, Glyceryl Stearate, Behenyl Alcohol, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Sodium Ascorbyl Phosphate, Stearic Acid, Palmitic Acid, Lauryl Alcohol, Myristyl Alcohol, Cetyl Alcohol, Lecithin, Caprylic/Capric Triglyceride, Chlorphenesin, Cellulose Gum, Butylated PVP, Disodium EDTA

Questions?

866-288-3330

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone®
SUNSCREEN LOTION

ULTRA
GUARD™

Broad
Spectrum
SPF
70+

Protection From The Most
Damaging UVA/UVB Rays

Non-Greasy

Water Resistant
(80 minutes)

70+

8 FL OZ (237 mL)

Principal Display Panel - 237 mL Bottle Label
COPPERTONE ULTRAGUARD   SPF 70 PLUS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7277
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30.63 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate153.15 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate51.05 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene102.1 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone61.26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Docosanol (UNII: 9G1OE216XY)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Palmitic Acid (UNII: 2V16EO95H1)  
Lauryl Alcohol (UNII: 178A96NLP2)  
Myristyl Alcohol (UNII: V42034O9PU)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Chlorphenesin (UNII: I670DAL4SZ)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Edetate Disodium (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7277-1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/21/1999
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 8/2014
Document Id: c2ed2ea0-9cf0-417c-a85e-b7d4bacc7e5b
Set id: 885c9067-3ad9-4966-9070-e76181e1809f
Version: 1
Effective Time: 20140820
 
MSD Consumer Care, Inc.