FDA.reportPublic FDA data

Reef Babies SPF 50 Oxybenzone Free

Product NDC
52854-515
11-digit product format
528540515
Labeler code
52854
Product ID
52854-515_42c9f018-98d9-575f-e063-6394a90a2566
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Reef Babies SPF 50 Oxybenzone Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cd68b09-2578-4519-b00e-e83e0e440815Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-515-01Reef Babies SPF 50 Oxybenzone Free120 mL in 1 BOTTLE, PLASTICLOTION1208
52854-515-02Reef Babies SPF 50 Oxybenzone Free192 mL in 1 BOTTLE, PLASTICLOTION1928

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-515REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]7Current NDC, Legacy NDC, 2 package rows20241103_8cd68b09-2578-4519-b00e-e83e0e440815.zip

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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields7fe05ef6-dd5f-4f25-bbf7-24f9396427072026-01-23WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen NacreCEILE SPF 30 PRIME PROTECT RADIATE NACRELE COSMETICS INC4915de09-3a2c-cb75-e063-6394a90a6a572026-01-23WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEAustralian Gold248d761c-2120-4019-9463-9952bc367e732026-01-23WarningsExact identifier
application number: M020
SOLBAR THIRTYSUNSCREENPerson and Covey48ed3be8-d146-ec2c-e063-6394a90a6c4d2026-01-22WarningsExact identifier
application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f557b5-a844-8c94-e063-6394a90af2202026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f5e9ab-38e0-f12c-e063-6294a90aab8b2026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREENZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDEAble C&C Co., Ltd.48f6361d-d738-62df-e063-6294a90aaac52026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 35 AVOSUNSCREENPerson and Covey4a5692d5-0835-d18f-e063-6394a90a29292026-01-22WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF15OCTINOXATE, AVOBENZONE, OCTISALATEDongguan Taimeng Accessories Co., Ltd.48f70710-7960-5fa5-e063-6394a90a4ce62026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 ZINCSUNSCREENPerson and Covey48fc01dd-0be4-5c63-e063-6294a90a23622026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 SHIELDSUNSCREENPerson and Covey48fcd463-8ce4-1e78-e063-6394a90a98e72026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 50 FIFTYSUNSCREENPerson and Covey48fef521-1b24-d0d5-e063-6394a90ac7b12026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7456f4bb-d0ec-439d-b807-d00b4c01c1112026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2dd51960-515f-4502-b261-5e5d5f57e0912026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5b835716-af13-4e23-bdae-d391864acb6f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa258570-ee21-423d-bad6-010d14792a862026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa84c1b5-a9b6-408e-b9fd-0dadebaf374e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6b7a016c-c3b1-4f90-80c9-fe47c52916492026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5d029d93-7f3d-4624-bcd7-40df9230414e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f724d68-3c6e-4b95-894e-78b2da220a302026-01-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-515-0152854051501120 mL in 1 BOTTLE, PLASTIC (52854-515-01) 120 ml2017-05-010000-00-00NoNoCurrent
52854-515-0252854051502192 mL in 1 BOTTLE, PLASTIC (52854-515-02) 192 ml2022-11-140000-00-00NoNoCurrent