FDA.reportPublic FDA data

Reef Babies SPF 50 Spray

Manufacturer
Tropical Seas, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:42:08

Label at a glance#

ProductReef Babies SPF 50 Oxybenzone Free
Active ingredientOCTOCRYLENE, OCTISALATE, 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 and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure do not spray directly on face - spray into hands and apply to face hold approximately 4 - 6 inches from skin to spray rub into skin evenly to ensure appropriate coverage use in a well-ventilated area avoid inhaling or exposing others to spray do not apply in windy conditions reapply: after 80 minutes of swimming or sweating immediately after towel drying at least ever...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10.0%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not use near heat, flame, or while smoking

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product:

  • Keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperatures above 120° F

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • do not spray directly on face - spray into hands and apply to face
  • hold approximately 4 - 6 inches from skin to spray
  • rub into skin evenly to ensure appropriate coverage
  • use in a well-ventilated area
  • avoid inhaling or exposing others to spray
  • do not apply in windy conditions
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive cold, heat, and direct sun.
  • store at temp below 90º F and avoid long term storage
  • may stain fabrics or surfaces

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-368-7327

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180ml NDC 52854-558-02

NDC 52854-558-02NDC 52854-558-02

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130079608515186GTIN-13: 0079608515186
EAN-13: 0079608515186
GTIN-12: 079608515186
UPC-A: 079608515186
GTIN storage (14 digits): 00079608515186		rb50spray6oz.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-558-02Reef Babies SPF 50 Oxybenzone Free180 mL in 1 CANSPRAY1808

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-55852854-558-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PHENETHYL BENZOATE0C143929GKIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LAURYL LACTATEG5SU0BFK7OIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
OCTYLDODECYL CITRATE CROSSPOLYMERX323T6QO4MIACT
ALCOHOL3K9958V90MIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-01full-release2026-06-01 00:33:30

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
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
ndc (package): 52854-558-02
ndc (product): 52854-558
ndc11 (package): 52854055802
spl id: 42ca59d6-ed3a-be73-e063-6394a90a8477
spl set id: d5ed3488-aa32-4a63-9996-12c6532c3a4d

Reported adverse events (FAERS/openFDA)#

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