SEAWEED OIL-CONTROL SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion

Seaweed Oil-Control SPF 15 by

Drug Labeling and Warnings

Seaweed Oil-Control SPF 15 by is a Otc medication manufactured, distributed, or labeled by Buth-Na-Bodhaige, Inc.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone (3.0% w/w)	Sunscreen
Octinoxate (2.9% w/w)	Sunscreen
Octisalate (5.0% w/w)	Sunscreen
Octocrylene (2.2% w/w)	Sunscreen

Uses

• helps prevent sunburn.

Warnings

• For external use only.

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• 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 value of 15 or higher and other sun protection measures including:
  • limit time in sun especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • reapply this product at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.
• children under 6 months of age: ask a doctor.

Other information

• protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Phenoxyethanol, Bertholletia Excelsa Seed Oil, Caprylyl Glycol, Fragrance, Xanthan Gum, Carbomer, Potassium Sorbate, Tetrasodium EDTA, Pentylene Glycol, Propylene Glycol, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fucus Vesiculosus Extract, Linalool, Zinc Gluconate, Benzyl Salicylate, Acacia Senegal Gum, Hydrolyzed Wheat Protein, Propylene Glycol Alginate, BHT, Hydrolyzed Algin, Serine, Sodium Stearate, Zinc Sulfate.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

THE
BODY
SHOP

THE BODY SHOP
SEAWEED

OIL-CONTROL LOTION
BROAD SPECTRUM SPF 15 SUNSCREEN

WITH MINERAL-RICH SEAWEED
FROM ROARING WATER BAY, IRELAND

50 ml (1.69 US FL OZ)

COMBINATION / OILY SKIN

INGREDIENTS AND APPEARANCE

SEAWEED OIL-CONTROL SPF 15 
octisalate, avobenzone, octinoxate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.029 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.022 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Sorbitol (UNII: 506T60A25R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
BRAZIL NUT OIL (UNII: 0G89T29HO6)
Caprylyl Glycol (UNII: 00YIU5438U)
Xanthan Gum (UNII: TTV12P4NEE)
Carboxypolymethylene (UNII: 0A5MM307FC)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Edetate Sodium (UNII: MP1J8420LU)
Pentylene Glycol (UNII: 50C1307PZG)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Hydroxide (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Benzyl Salicylate (UNII: WAO5MNK9TU)
ACACIA (UNII: 5C5403N26O)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
Propylene Glycol Alginate (UNII: 26CD3J2R0C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Serine (UNII: 452VLY9402)
Sodium Stearate (UNII: QU7E2XA9TG)
Zinc Sulfate, Unspecified Form (UNII: 89DS0H96TB)
SODIUM ALGINATE (UNII: C269C4G2ZQ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-904-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/14/2016

Labeler - Buth-Na-Bodhaige, Inc., (791071279)