FDA.reportPublic FDA data

Glow Baby Brightening Setting Mist SPF 45

Manufacturer
Pacifica Beauty, LLC | Bell International Laboratories, Incorporated
Effective date
2025-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:44

Label at a glance#

ProductGlow Baby Brightening Setting Mist SPF 45
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure10 sections

Indications and 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.

Dosage and administration

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 protectio...

Storage and handling

Protect this product from excessive heat & direct sun.

Label contents#

Full prescribing information#

Active ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.9 % Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

Uses

OTC - PURPOSE SECTION

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 SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat & direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

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

Glow Baby Brightening Setting Mist SPF 45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glow Baby Brightening Setting Mist SPF 45Glow Baby Brightening Setting Mist SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61197-205-00Glow Baby Brightening Setting Mist SPF 45118 mL in 1 BOTTLE, PUMPSPRAY1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61197-205GLOW BABY BRIGHTENING SETTING MIST SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PACIFICA BEAUTY, LLC]2Current NDC, 1 package rows20250105_f2f53cf9-3717-07ff-e053-2a95a90a03fb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61197-20561197-205-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
FUCUS SERRATUSV8K40WNW5BIACT
ASCOPHYLLUM NODOSUM168S4EO8YJIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
ETHYL FERULATE5B8915UELWIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
LAMINARIA DIGITATA15E7C67EE8IACT
GLYCERINPDC6A3C0OXIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCONUT ALKANES1E5KJY107TIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact identifier
ndc (package): 61197-205-00
ndc (product): 61197-205
ndc11 (package): 61197020500
spl id: 2ad4b484-e530-52a5-e063-6394a90a8751
spl set id: f2f53cf9-3717-07ff-e053-2a95a90a03fb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.