Sunscreen for Babies

Sunscreen for Babies

Drug Labeling and Warnings

Drug Details

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SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray 
Family Dollar Services, 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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Sunscreen for Babies

Active ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 7%

Oxybenzone 4%

Purpose

Sunscreen

Use

  • 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 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 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

  • protect the product from excessive heat and direct sun

Inactive ingredients

water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopherol, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Water Babies Broad Spectrum SPF 50

Distributed by Family dollar Services Inc.

10401 Monroe Rd.

Matthews, NC 28105, USA

Principal Display Panel

Tropic Sun

Sunscreen for Babies

Broad spectrum SPF 50

Compare to Coppertone Water Babies Sunscreen*

SPF 50

Water resistant (80 minutes)

UVA/UVB sunscreen

Pediatrician tested

Paraben free

3 FL OZ (89 mL)

image description

752.000/752AB

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-752
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone30.9 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate133.9 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate51.5 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone41.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
tocopherol (UNII: R0ZB2556P8)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-752-2189 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2017
2NDC: 55319-752-34236 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/07/2017
Labeler - Family Dollar Services, Inc (024472631)
Registrant - Vi-Jon, Inc. (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc.790752542manufacture(55319-752)

Revised: 12/2018
 
Family Dollar Services, Inc


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