Label: GLOW BABY BRIGHTENING SETTING MIST SPF 45- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 61197-205-00
- 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 January 23, 2023
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- Active ingredients Purpose
- Uses
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
Shake well before use. Apply liberally 15 minutes before sun exposure. Use water-resistant sunscreen if swimming or sweating. Reapply after swimming or sweating. Reapply at least every 2 hours.
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:
Alcohol Denat., Butyloctyl Salicylate, Diheptyl Succinate, Silica Silylate, Coconut Alkanes, Parfum (Natural), Tetrahexyldecyl Ascorbate (Vitamin C), Algae Extract, Ascophyllum Nodosum (Seaweed) Extract, Laminaria Digitata (Algae) Extract, Aqua, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Glycerin, Bisabolol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco Caprylate/Caprate, Ethyl Ferulate.
- Other information
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- Glow Baby Brightening Setting Mist SPF 45
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INGREDIENTS AND APPEARANCE
GLOW BABY BRIGHTENING SETTING MIST SPF 45
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 mg in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 mg in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) FUCUS SERRATUS (UNII: V8K40WNW5B) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) ETHYL FERULATE (UNII: 5B8915UELW) LAMINARIA DIGITATA (UNII: 15E7C67EE8) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) COCONUT ALKANES (UNII: 1E5KJY107T) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-205-00 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/23/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Incorporated 967781555 manufacture(61197-205)
