GLOW BABY SUPER LIT SPF 30- zinc oxide spray 
Pacifica Beauty, LLC

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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Glow Baby Super Lit SPF 30 Lotion

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.

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.

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

Glow Baby Super Lit SPF 30 Lotion Label

GLOW BABY SUPER LIT SPF 30 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-217
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-217-0050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/03/2023
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Sun Deep Inc.189788201manufacture(61197-217)

Revised: 2/2023
Document Id: f3d3eee2-a5da-113b-e053-2995a90a7057
Set id: f3d3eee2-a5d9-113b-e053-2995a90a7057
Version: 1
Effective Time: 20230203
 
Pacifica Beauty, LLC