SUNSCREEN- zinc oxide, titanium dioxide lotion

sunscreen by

Drug Labeling and Warnings

sunscreen by is a Otc medication manufactured, distributed, or labeled by giggle. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

• Active Ingredients: Purpose
• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70306-5357
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70306-5357-4	118 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2016

Labeler - giggle (194045402)