SUNSCREEN SPF50- avobenzone , homosalate , octisalate , oxybenzone , octocrylene lotion 
SKIN KIDZ CC

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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Sun Skin SPF50 Sunscreen

PURPOSE

Sunscreen

Uses

● helps prevent sunburn

● if used as directed with other sun protection measures

Active ingredients

Avobenzone 3%, Homosalate 11.7%,
Octisalate 4.5%, Oxybenzone 5.4%,
Octocrylene 4.5%

Directions 

● apply generously 15 minutes before sun exposure

● ensure complete coverage to the are above the lip, nose, and tops of ears

● reapply: - after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours.

WARNING AND Pracaution

●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.

●If rash occurs, stop use and ask a doctor 

ASK DOCTOR SECTION

●If rash occurs, stop use and ask a doctor

KEEP OUT OF REACH OF CHILDREN SECTION

INACTIVE INGREDIENT

ingredients: water, propylene glycol,
polyurethane-34, cetyl alcohol, potassium cetyl
phosphate, glycerin, sorbitan mono stearate,
polysorbate 60, phenoxyethanol,
ethylhexylglycerin, potassium hydroxide,
dimethicone, tocopheryl acetate, acrylates/C10-
30 alkyl acrylate crosspolymer, arginine, sodium
ascorbyl phosphate, disodium EDTA

Product Label 

front imagedrug facts

SUNSCREEN  SPF50
avobenzone , homosalate , octisalate , oxybenzone , octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72376-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE117 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE54 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Propylene glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)  
Cetyl alcohol (UNII: 936JST6JCN)  
Potassium cetyl phosphate (UNII: 03KCY6P7UT)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitan monostearate (UNII: NVZ4I0H58X)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Potassium hydroxide (UNII: WZH3C48M4T)  
Dimethicone (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Arginine (UNII: 94ZLA3W45F)  
Sodium ascorbyl phosphate (UNII: 836SJG51DR)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72376-001-0151 g in 1 BOTTLE; Type 0: Not a Combination Product06/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/11/2018
Labeler - SKIN KIDZ CC (538908603)
Establishment
NameAddressID/FEIBusiness Operations
SKIN KIDZ CC538908603manufacture(72376-001)

Revised: 6/2018
Document Id: e897b9bb-5d62-469b-a29b-2ca645745561
Set id: 9819e603-8a87-408a-839d-e325493590aa
Version: 1
Effective Time: 20180622
 
SKIN KIDZ CC