BABYGANICS SPF 50- octinoxate, octisalate, and zinc spray 
Autumn Harp, 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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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

Label

BABYGANICS  SPF 50
octinoxate, octisalate, and zinc spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0235
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide112 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0235-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/21/2013
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/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0235)

Revised: 11/2018
Document Id: 87630dc9-73ce-4ec1-bb04-d08159ec6aba
Set id: f40a8efa-2cbe-4e99-aba3-66eb59b70332
Version: 3
Effective Time: 20181115
 
Autumn Harp, Inc.