Drug Facts

SEA PURE HYDRATING SEA PURE HYDRATING SPF20- titanium dioxide lotion
H2O PLUS

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.

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Drug Facts

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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Image of carton label sphl295.jpg

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - H2O PLUS (807722947)