Babyganics SPF 50

Dosage form: spray
Ingredients: Zinc Oxide 11.2mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5.0mL in 100mL
Labeler: Autumn Harp, Inc.
NDC Code: 51514-0235

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

Active Ingredients

Active Ingredients                                                      Purpose

Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 11.2%     Sunscreen

Uses

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

Warnings

For external use only

Do not use

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.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

children under 6 months of age: ask a doctor

Sun Protection Measures

Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin aging. To decrease this risk sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 am - 2 pm.

wear long-sleeved shirts, pants, hats, andsunglasses

Other Information

Other information

protect from excessive heat and direct sun

Inactive ingredients

Inactive Ingredients:  Water, Glycerin, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, VP/hexadecene copolymer, Cetearyl Glucoside, Phenethyl Alcohol, Glyceryl Caprylate, Polyacrylate Crosspolymer-6, Cetearyl Alcohol, Citric Acid.

Label

BABYGANICS  SPF 50
octinoxate, octisalate, and zinc spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0235
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide11.2 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:51514-0235-1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/23/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIOperations
Autumn Harp, Inc.064187883manufacture

Revised: 03/2012
 
Autumn Harp, Inc.

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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