GLOW BABY SUPER LIT SPF 30- zinc oxide spray

Glow Baby Super Lit SPF 30 by

Drug Labeling and Warnings

Glow Baby Super Lit SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients Purpose

Zinc Oxide 20.8% Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

INDICATIONS & USAGE

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Can stain clothing. Keep away from clothes. Children under 6 months: ask a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Apply and reapply at least every 80 minutes. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.

Inactive ingredients:

Aqua (Eau), Allantoin, Ascorbic Acid, Bisabolol, Bismuth Oxychloride, Butyloctyl Salicylate, Caffeine, Caprylhydroxamic acid, Caprylic/ Capric Triglyceride, Citric Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Iron Oxides (CI 77491, CI 77492, CI 77499), Jojoba Esters, Malus Domestica Fruit Cell Culture Extract, Mica, Parfum*, Polyglyceryl-6 Distearate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil (and) Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Sesquioleate, Terminalia Ferdinandiana Fruit Extract, Titanium Dioxide, Tocopherol (Vitamin E), Tocopheryl Acetate, Xanthan Gum.

Other information

Protect this product from excessive heat & direct sun.

Questions or comments?

Call toll free 1-888-322-2466
Pacifica Beauty LLC Portland, Oregon

Glow Baby Super Lit SPF 30 Lotion Label

INGREDIENTS AND APPEARANCE

GLOW BABY SUPER LIT SPF 30 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICA (UNII: V8A1AW0880)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-217-00	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/03/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	manufacture(61197-217)