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 344 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CalicoOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS96437795-906f-4e11-ac69-c0c2ae264aae2021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CashewOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb5527aba-5856-44cd-a1d5-f2d7cefb45ea2021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS9b641ccb-3046-4b21-8164-b80813090cb42021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2500fe73-00e2-47ba-9e2b-1c268ed4a9e62021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS4df1b021-5028-456e-87f2-a96ea6c26c7b2021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS830a485c-53d4-4fa9-b0cd-0fd2a9bd234b2021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8a9fe755-32a2-49b0-8c78-f84bd2ba148f2021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc5f3f1bc-adca-495f-b1bc-51c91d42a4802021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 UberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS64db3a1f-d6c7-4766-a52c-a4b0c39e26332021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 WalnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS582a8244-dab8-4861-9115-2e895a586fb92021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply BronzeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS377405a6-b6c6-4afb-9270-73d9330290542021-07-13WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9f7c8d53-6549-4bac-bbae-a2b73fdf6b052021-07-12WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS5a22b123-9077-4b8a-ac4c-1bdd475c6ac32021-07-12WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 CalicoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS4647828c-661d-4ebe-b27e-13d8b89647b82021-07-12WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASc82f36da-16ce-45f4-9786-2026a359060a2021-07-12WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 WheatOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS3d86dca5-9e33-4284-a4c1-f5eed64b06202021-07-12WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 WillowOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS0489a046-2173-4137-abff-c6a7cdb5e8fd2021-07-12WarningsExact identifier
application number: M020
H.E.B. Solutions SunscreenSPORT SPF 70 LOTIONH.E.B00cade74-9a8f-4af9-a809-ebf0ff2bbc3c2021-07-09WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenKIDS SPF 70 LOTIONH.E.B9f08c40e-b5c6-4ca4-8c24-0a0f987872172021-07-09WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 50 LOTIONH.E.B6e45677e-1066-498e-b423-109a94a152aa2021-07-09WarningsExact 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