STREAM2SEA BROAD SPECTRUM 30- titanium dioxide lotion STREAM2SEA BROAD SPECTRUM 20- titanium dioxide lotion

Stream2Sea Broad Spectrum 20 - Tinted by

Drug Labeling and Warnings

Stream2Sea Broad Spectrum 20 - Tinted by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. For children under 6 months of age; ask a doctor.

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. RInse with water to remove.

Stream2Sea Broad Spectrum Sport Face & Body SPF 20 3oz

Stream2Sea Broad Spectrum Sport Face & Body SPF 30 1oz

Stream2Sea Broad Spectrum Sport Face & Body SPF 30 3oz

Stream2Sea Braod Spectrum Sport SPF 20 1oz Principal Display

INGREDIENTS AND APPEARANCE

STREAM2SEA BROAD SPECTRUM 30 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 g  in 88 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBIC ACID (UNII: X045WJ989B)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-030-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2015
2	NDC: 69555-030-03	90 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2015

STREAM2SEA BROAD SPECTRUM 20 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 g  in 66 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARYL PALMITATE (UNII: UVI52NPK6G)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBIC ACID (UNII: X045WJ989B)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
CETYL PALMITATE (UNII: 5ZA2S6B08X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-020-03	90 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2015
2	NDC: 69555-020-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2015

Labeler - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(69555-030, 69555-020)