SEA AND C GLOW BRONZING BODY OIL SPF 20- avobenzone, octisalate, octocrylene liquid 
Pacifica Beauty, LLC

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Sea and C Glow Bronzing Body Oil SPF 20

Active ingredients Purpose

Avobenzone 2.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% 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.

Keep out of reach of children.

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.

Inactive ingredients:

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

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

Questions or comments?

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

Sea and C Glow Bronzing Body Oil SPF 20 Label

SEA AND C GLOW BRONZING BODY OIL SPF 20 
avobenzone, octisalate, octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAFFEINE (UNII: 3G6A5W338E)  
MICA (UNII: V8A1AW0880)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-214-00118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/02/202305/15/2024
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Incorporated967781555manufacture(61197-214)

Revised: 5/2024
Document Id: 1880d1a3-bd7b-779c-e063-6394a90a46ec
Set id: f3bd0036-db0e-91e9-e053-2a95a90a1066
Version: 2
Effective Time: 20240515
 
Pacifica Beauty, LLC