Label: GLOW BABY SUPER LIT SPF 30- zinc oxide spray
- NDC Code(s): 61197-217-00
- Packager: Pacifica Beauty, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 3, 2023
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- Active ingredients Purpose
- Uses
- INDICATIONS & USAGE
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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
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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.
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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.
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- Glow Baby Super Lit SPF 30 Lotion Label
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INGREDIENTS AND APPEARANCE
GLOW BABY SUPER LIT SPF 30
zinc oxide sprayProduct 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)
