REEF BABIES SPF 50 OXYBENZONE FREE- octocrylene, octisalate, and avobenzone lotion 
Tropical Seas, Inc.

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Reef Babies SPF 50 Lotion

Drug Facts

Active Ingredients

Octocrylene 10.0%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid, glyceryl stearate se, cetyl dimethicone, glycerin, sodium hydroxide, emulsifying wax, tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol, methylparaben, diazolidinyl urea, propylparaben, and caprylyl glycol.

Other Information

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - 120 mL Bottle Label

120ml NDC 52854-515-01 120ml front label120ml back label

192ml NDC 52854-515-02

NDC 52854-515-02

REEF BABIES SPF 50 OXYBENZONE FREE 
octocrylene, octisalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CHAMOMILE (UNII: FGL3685T2X)  
SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
AMERICAN GINSENG (UNII: 8W75VCV53Q)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-515-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2017
2NDC:52854-515-02192 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/01/2017
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-515)

Revised: 10/2023
Document Id: 06bf768f-6c0e-a4d9-e063-6394a90ad050
Set id: 8cd68b09-2578-4519-b00e-e83e0e440815
Version: 6
Effective Time: 20231002
 
Tropical Seas, Inc.