Label: SUN BATHE SUNSCREEN SPF 20- avobenzone, octinoxate, octocrylene soap
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Contains inactivated NDC Code(s)
NDC Code(s): 70342-102-13 - Packager: BABY BUBBA ENTERPRISES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 19, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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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
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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?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN BATHE SUNSCREEN SPF 20
avobenzone, octinoxate, octocrylene soapProduct 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)
