SUNSCREEN- zinc oxide, titanium dioxide lotion 
giggle

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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giggle sunscreen for early 2016

Active Ingredients

Active IngredientsPurpose
Titanium Dioxide: 7.0%Sunscreen
Zinc Oxide: 9.0%Sunscreen

Warnings

For external use only.

When using this product - avoid damaged/broken skin - avoid contact with eyes. Rinse well with cool 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

Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming/sweating, immediately after towel drying, and at least every 2 hours. Children under 6 months: ask a doctor.

Sun Protection Measures: Spending time in sun increases risk of skin cancer and early skin aging. To decrease risk, use sunscreen with Broad Spectrum SPF 15 or higher and limit time in sun especially 10am-2pm, and wear long-sleeved shirts, pants, hats, sunglasses.

Inactive Ingredients

Inactive Ingredients Water, Coconut Alkanes, Caprylic/Capric Triglyceride, Isoamyl Laurate, Aloe Barbadensis Leaf Juice (1), Crambe Abyssinica Seed Oil, Glycerin, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate/Caprate, Stearic Acid, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Alumina, Phenoxyethanol, Benzyl Alcohol, Brassica Campestris (Rapeseed) Oil, Camilla Sinesis Leaf Extract (1), Echinacea Purpurea Extract, Ginkgo Biloba Leaf Extract (1), Polygonum Aviculare Extract (1)Certified Organic Ingredient

Questions? Visit giggle.com or call 800-495-8577.

Sunscreen label

SUNSCREEN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70306-5357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-2 SESQUIISOSTEARATE (UNII: LA272Q68GQ)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SHEA BUTTER (UNII: K49155WL9Y)  
GINKGO (UNII: 19FUJ2C58T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
Colorwhite (Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70306-5357-4118 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2016
Labeler - giggle (194045402)

Revised: 12/2015
Document Id: 25db0c84-8b91-5637-e054-00144ff88e88
Set id: 25db0c84-8b90-5637-e054-00144ff88e88
Version: 1
Effective Time: 20151201
 
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