Moderate Protection Sun SPF 15

Dosage form: spray
Ingredients: Octocrylene 20mL in 200mL, Octinoxate 15mL in 200mL, Avobenzone 6mL in 200mL, Sulisobenzone 4mL in 200mL
Labeler: Babor Cosmetics America, Corp
NDC Code: 44924-100

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.

Drug Facts insert



Drug Facts

Active Ingredients                      Purpose
octinoxate, octocrylene,            sunscreens             
avobenzone, sulisobenzone

Uses
Sunscreen to help prevent sunburn.
Allows you to stay in the sun up to 15 times longer than without sunscreen protection.
Protects from the sun to help prevent skin damage.

Warnings
For external use only
Do not swallow, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Allergy Alert
If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash persists.

Keep this out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Store at room temperature.

Directions
Adults and children 6 months of age and over: Apply liberally as often as necessary.
Children under 2 years of age should use sunscreen products with a minimum SPF of 4.
Children under 6 months of age: Consult a doctor. 
 
Inactive Ingredients

water (aqua), C12 15 alkyl benzoate, butylene glycol, cocoglycerides, dicaprylyl carbonate, polyglyceryl 5 laurate, tocopheryl acetate, phenoxyethanol, panthenol, glycerin, fragrance (parfum), acetamide MEA, sodium hydroxide, acrylates C10 30 alkyl acrylate crosspolymer, disodium EDTA, ethylhexylglycerin, potassium sorbate, cassia alata leaf extract, caprylic capric triglyceride, biosaccharide gum 4, biosaccharide gum 1, sodium carboxymethyl betaglucan, ascorbyl tetraisopalmitate, tocopherol, pantolactone, ethylparaben, methylparaben, propylparaben, carbomer, citric acid, DNA. 
 
 

Carton panel description



A oil free, water resistant spray lotion for skin that is sensitive to the sun and prone to sun allergies. Contains a moderate sun protection factor to protect the face and body from sunburn.
The innovative, anti aging formula, which is based on the BABOR SKIN PROTECTION COMPLEX (SPC+), increases the skin’s natural defenses before sun exposure, inhibits the formation and spread of free radicals during sun exposure and promotes sustained cell regeneration after sun exposure.
In combination with broad spectrum UVA and UVB filters, SPC+ thus effectively combats premature, light induced skin aging. 

Carton panel inactive ingredients




Inactive Ingredients

water (aqua), C12 15 alkyl benzoate, butylene glycol, cocoglycerides, dicaprylyl carbonate, polyglyceryl 5 laurate, tocopheryl acetate, phenoxyethanol, panthenol, glycerin, fragrance (parfum), acetamide MEA, sodium hydroxide, acrylates C10 30 alkyl acrylate crosspolymer, disodium EDTA, ethylhexylglycerin, potassium sorbate, cassia alata leaf extract, caprylic capric triglyceride, biosaccharide gum 4, biosaccharide gum 1, sodium carboxymethyl betaglucan, ascorbyl tetraisopalmitate, tocopherol, pantolactone, ethylparaben, methylparaben, propylparaben, carbomer, citric acid, DNA. 

MODERATE PROTECTION SUN SPF 15 
octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44924-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (Octocrylene) Octocrylene20 mL  in 200 mL
Octinoxate (Octinoxate) Octinoxate15 mL  in 200 mL
Avobenzone (Avobenzone) Avobenzone6 mL  in 200 mL
Sulisobenzone (Sulisobenzone) Sulisobenzone4 mL  in 200 mL
Packaging
#Item CodePackage Description
1NDC:44924-100-021 BOTTLE, SPRAY (BOTTLE) in 1 CARTON
1NDC:44924-100-01200 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2010
Labeler - Babor Cosmetics America, Corp (139251763)
Establishment
NameAddressID/FEIOperations
Dr. Babor GMBH & Co. KG315989384manufacture

Revised: 03/2010
 
Babor Cosmetics America, Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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