SEA RESULTS LINE RESOLUTION SEA RESULTS LINE RESOLUTION SPF30- avobenzone,homosalate,octisalate,oxybenzone cream

Sea Results Line Resolution by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%

Sunscreen
Sunscreen
Sunscreen
Sunscreen

Helps prevent sunburn
If used as directed with other sun protection measures
(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 if rash occurs

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 15 minutes before sun exposure
Use water resistance sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor

Protect the product in this container from excessive heat
and direct sun

Acetyl Hexapeptide-8, Alcohol, Aqua/Water/Eau,
Benzoic Acid, Butylene Glycol, Butylparaben,
C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl
Glucoside, Cyclopentasiloxane, Dehydroacetic
Acid, Dimethicone, Ethylhexylglycerin,
Ethylparaben, Glycerin, Glyceryl Stearate,
Himanthalia Elongata Extract, Isobutylparaben,
Linalool, Magnesium Ascorbyl Phosphate,
Methylisothiazolinone, Methylparaben,
Panthenol, Parfum/Fragrance, Phenoxyethanol,
Phospholipids, Polyaminopropyl Biguanide,
Porphyra Umbilicalis Extract, Potassium Sorbate,
Propylparaben, Retinyl Palmitate, Silica,
Solidago Virgaurea (Goldenrod) Extract,
Spirulina Maxima Extract, Tocopheryl Acetate,
Triethanolamine, Trisiloxane, Tropaeolum Majus
Flower Extract, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Image of Label Carton srlr276.jpg

INGREDIENTS AND APPEARANCE

SEA RESULTS LINE RESOLUTION  SEA RESULTS LINE RESOLUTION SPF30
avobenzone,homosalate,octisalate,oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	8 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LINALOOL, (+)- (UNII: F4VNO44C09)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)
TRISILOXANE (UNII: 9G1ZW13R0G)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-276-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2012

Labeler - H2O PLUS (807722947)