FDA.reportPublic FDA data

SUN BATHE SUNSCREEN

Manufacturer
BABY BUBBA ENTERPRISES INC | Bradford Soap Works, Inc.
Effective date
2017-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:41

Label at a glance#

ProductSUN BATHE SUNSCREEN SPF 20
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure11 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 REAPPLY: 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 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 SUNGL...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE    1.6%

OCTINOXATE    5.2%

OCTOCRYLENE    4.2%

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
  • DO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES AND RINSE WITH EXCESSIVE WATER TO REMOVE.

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.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION OCCURS.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  • 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 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.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, PROPYLENE GLYCOL, SODIUM STEARATE, GLYCERIN, SODIUM LAURETH SULFATE, SORBITOL, SODIUM LAURYL SULFATE, SODIUM MYRISTATE, SODIUM COCOYL ISETHIONATE, ACRYLATES COPOLYMER, FRAGRANCE (PARFUM), TRIETHANOLAMINE, TITANIUM DIOXIDE (CI 77891), POLYQUATERNIUM-16, SILICA, TETRASODIUM ETIDRONATE, PENTASODIUM PENTETATE, YELLOW 10 (CI 47005), POLYAMIDE-3, SORBITAN OLEATE, POLYSORBATE 20, CELLULOSE GUM, PEG-16, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, PG-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

PLEASE CALL TOLL FREE 1-844-799-SOAP

WWW.SUNBATHESOAP.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Bathe Sunscreen Soap_UC_cropped 2Sun Bathe Sunscreen Soap_UC_cropped 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70342-102-132020-01-31C16284748780-19d75b9d0-e305-f424-e053-dadaa90a57cee4825f96-0ca8-40ed-a0ad-b2281919181e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70342-102-13SUN BATHE SUNSCREENSPF 2099 g in 1 PACKAGESOAP991

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70342-102SUN BATHE SUNSCREEN SPF 20 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) SOAP [BABY BUBBA ENTERPRISES INC]1Legacy NDC, 1 package rows20170620_e4825f96-0ca8-40ed-a0ad-b2281919181e.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70342-10270342-102-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STEARATEQU7E2XA9TGIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM MYRISTATE06BLC4V0IVIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5))1KX12A42IJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
EDETATE SODIUMMP1J8420LUIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
POLYAMIDE-3 (30000 MW)9AO559AXEBIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
POLYSORBATE 207T1F30V5YHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
POLYETHYLENE GLYCOL 800UH6KR4953DIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PROPYLENE GLYCOL-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE3479326GXBIACT

Source Document#

Source XML

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
e99214c2-e15f-419c-92a5-cc21c90e0381e4825f96-0ca8-40ed-a0ad-b2281919181e2017-06-19WarningsExact identifier
spl id: e99214c2-e15f-419c-92a5-cc21c90e0381
spl set id: e4825f96-0ca8-40ed-a0ad-b2281919181e

Reported adverse events (FAERS/openFDA)#

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