SEA PURE HYDRATING SEA PURE HYDRATING SPF20- titanium dioxide lotion

Sea Pure Hydrating by

Drug Labeling and Warnings

Sea Pure Hydrating by is a Otc medication manufactured, distributed, or labeled by H2O PLUS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide4.0%

Helps prevent sunburns
If used as directed with other sun protection measure ( see directions)decreases the risk of skin
cancers/ and early skin aging

For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor is a rash occurs
When using this product* keep out of eyes, Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison control center right
away

For Sunscreen Use
Apply Liberally
Children under six months of age: Ask a doctor

Protect this product in this container from excessive heat and direct sunlight

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PRINCIPAL DISPLAY PANEL

Image of carton label sphl295.jpg

INGREDIENTS AND APPEARANCE

SEA PURE HYDRATING  SEA PURE HYDRATING SPF20
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 uL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CORN OIL (UNII: 8470G57WFM)
JOJOBA OIL (UNII: 724GKU717M)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIMONENE, (-)- (UNII: 47MAJ1Y2NE)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
XANTHAN GUM (UNII: TTV12P4NEE)
ULVA COMPRESSA (UNII: SXZ209FM33)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
TOCOPHEROL (UNII: R0ZB2556P8)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LEMON OIL (UNII: I9GRO824LL)
ROSEMARY OIL (UNII: 8LGU7VM393)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
LIME OIL (UNII: UZH29XGA8G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-295-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/10/2010

Labeler - H2O PLUS (807722947)