FDA.reportPublic FDA data

Sea and C Glow Bronzing Body Oil SPF 20

Manufacturer
Pacifica Beauty, LLC | Bell International Laboratories, Incorporated
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:38:29

Label at a glance#

ProductSea and C Glow Bronzing Body Oil SPF 20
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE
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 protection m...

Storage and handling

Protect this product from excessive heat & direct sun. Can stain clothing, keep away from clothes.

Label contents#

Full prescribing information#

Active ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.8% 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

Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Silica Silylate, Parfum (Natural), Simmondsia Chinensis (Jojoba) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Caffeine, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Laminaria Digitata (Algae) Extract, Laminaria Hyperborea (Kelp) Extract, Hippophae Rhamnoides Oil, Bisabolol, Calcium Sodium Borosilicate, Heptyl Undecylenate, Iron Oxides, Mica, Octyldodecyl Oleate, Tin Oxide, Titanium Dioxide.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat & direct sun. Can stain clothing, keep away from clothes.

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sea and C Glow Bronzing Body Oil SPF 20 LabelSea and C Glow Bronzing Body Oil SPF 20 Label

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61197-21461197-214-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAFFEINE3G6A5W338EIACT
MICAV8A1AW0880IACT
OCTISALATE4X49Y0596WACTIB
SAFFLOWER OIL65UEH262ISIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
OCTOCRYLENE5A68WGF6WMACTIB
LAMINARIA HYPERBOREANXA595GQ1KIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LAMINARIA DIGITATA15E7C67EE8IACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
AVOBENZONEG63QQF2NOXACTIB
HEPTYL UNDECYLENATEW77QUB6GXOIACT
FERRIC OXIDE RED1K09F3G675IACT
STANNIC OXIDEKM7N50LOS6IACT
SUNFLOWER OIL3W1JG795YIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL724GKU717MIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT

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
1880d1a3-bd7b-779c-e063-6394a90a46ecf3bd0036-db0e-91e9-e053-2a95a90a10662024-05-15WarningsExact identifier
spl set id: f3bd0036-db0e-91e9-e053-2a95a90a1066

Reported adverse events (FAERS/openFDA)#

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