Coppertone Waterbabies Sunscreen SPF 50

Product NDC
66800-4109
11-digit product format
668004109
Labeler code
66800
Product ID
66800-4109_4746e3ec-5fc5-d700-e063-6394a90a7e30
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-02
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
9; 4.5; 9; 3 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage66800-4109-6
excluded packagepackage66800-4109-0
excluded packagepackage66800-4109-3
excluded packagepackage66800-4109-9
excluded packagepackage66800-4109-2
excluded packagepackage66800-4109-8
excluded packagepackage66800-4109-1

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
Coppertone Waterbabies Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE9 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE9 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal 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
d915cb28-2813-5a38-e053-2a95a90a45c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4109-0Coppertone Waterbabies Sunscreen SPF 50296 g in 1 BOTTLE, PLASTICLOTION2966
66800-4109-1Coppertone Waterbabies Sunscreen SPF 5030 g in 1 TUBELOTION306
66800-4109-2Coppertone Waterbabies Sunscreen SPF 5059 g in 1 TUBELOTION596
66800-4109-3Coppertone Waterbabies Sunscreen SPF 5088 g in 1 TUBELOTION886
66800-4109-6Coppertone Waterbabies Sunscreen SPF 50177 g in 1 BOTTLE, PLASTICLOTION1776
66800-4109-8Coppertone Waterbabies Sunscreen SPF 50237 g in 1 BOTTLE, PLASTICLOTION2376
66800-4109-9Coppertone Waterbabies Sunscreen SPF 50315 g in 1 BOTTLE, PLASTICLOTION3156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-4109COPPERTONE WATERBABIES SUNSCREEN SPF 50 (AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%) LOTION [BEIERSDORF INC]4Current NDC, Legacy NDC, 7 package rows20250115_d915cb28-2813-5a38-e053-2a95a90a45c6.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 3 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact identifier
application number: M020
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-4109-066800410900296 g in 1 BOTTLE, PLASTIC (66800-4109-0) 296 g2020-11-020000-00-00NoNoCurrent
66800-4109-16680041090130 g in 1 TUBE (66800-4109-1) 30 g2020-11-020000-00-00NoNoCurrent
66800-4109-26680041090259 g in 1 TUBE (66800-4109-2) 59 g2020-11-020000-00-00NoNoCurrent
66800-4109-36680041090388 g in 1 TUBE (66800-4109-3) 88 g2020-11-020000-00-00NoNoCurrent
66800-4109-666800410906177 g in 1 BOTTLE, PLASTIC (66800-4109-6) 177 g2020-11-020000-00-00NoNoCurrent
66800-4109-866800410908237 g in 1 BOTTLE, PLASTIC (66800-4109-8) 237 g2020-11-020000-00-00NoNoCurrent
66800-4109-966800410909315 g in 1 BOTTLE, PLASTIC (66800-4109-9) 315 g2020-11-020000-00-00NoNoCurrent