SUN BATHE SUNSCREEN SPF 20- avobenzone, octinoxate, octocrylene soap

SUN BATHE SUNSCREEN by

Drug Labeling and Warnings

SUN BATHE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by BABY BUBBA ENTERPRISES INC, Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE    1.6%

OCTINOXATE    5.2%

OCTOCRYLENE    4.2%

PURPOSE

SUNSCREEN

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.

WARNINGS

• 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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

STOP USE

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

DIRECTIONS

• 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

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

INACTIVE INGREDIENTS

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?

PLEASE CALL TOLL FREE 1-844-799-SOAP

WWW.SUNBATHESOAP.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN BATHE SUNSCREEN  SPF 20
avobenzone, octinoxate, octocrylene soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70342-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STEARATE (UNII: QU7E2XA9TG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) (UNII: 1KX12A42IJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
POLYAMIDE-3 (30000 MW) (UNII: 9AO559AXEB)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE (UNII: 3479326GXB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70342-102-13	99 g in 1 PACKAGE; Type 0: Not a Combination Product	06/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/23/2016

Labeler - BABY BUBBA ENTERPRISES INC (079865347)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(70342-102)