REPAIR AND PROTECT MOISTURIZER BROAD SPECTRUM SPF30- avobenzone, dimethicone, homosalate, octisalate, octocrylene, oxybenzone cream

Repair and Protect Moisturizer Broad Spectrum SPF30 by

Drug Labeling and Warnings

Repair and Protect Moisturizer Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Strivectin Operating Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.00%

Dimethicone 1.50%

Homosalate 5.00%

Octisalate 5.00%

Octocrylene 2.79%

Oxybenzone 5.00%

Purpose

Sunscreen, Skin Protectant

Uses

Temporarily protects and helps relieve chafed or chapped skin.
Helps prevent and protect from the drying effects of wind and cold weather.
Helps prevent sunburn.
Higher SPF gives more sunburn protection.

Warnings

• ​For External Use Only

Do not use

• on damaged or broken skin.
• on deep or puncture wounds
• animal bites
• serious burns.

Stop use and ask a doctor if

rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within
a few days.

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.

Directions

apply liberally 15 minutes before sun exposure and as needed.
use a water resistant sunscreen if swimming or sweating.
reapply at least every 2 hours.
children under 6 months of age: Ask a doctor.

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 the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive Ingredients:

Aqua (Water, Eau), Styrene/Acrylates Copolymer, Ethylhexyl Benzoate, Myristyl Nicotinate, Glycerin, Caprylyl Methicone, Cyclopentasiloxane, Behenyl Alcohol, Nylon-6/12, C12-15 Alkyl Benzoate, Glyceryl Stearate, PEG-100 Stearate, Steareth-21, Thermus Thermophillus Ferment, Eugenia Caryophyllus (Clove) Flower Extract, Algae Extract, Palmitoyl Hexapeptide-12, Sodium Hyaluronate, Palmitoyl Tripeptide-5, Tribehenin, Erythritol, Caprylyl Glycol, Lauroyl Lysine, Ethylhexylglycerin, Ceramide NG, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Homarine HCI, Parfum (Fragrance), Limonene, Hydroxycitronellal, Benzyl Salicylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Tetrasodium Glutamate Diacetate, PEG-10 Phytosterol, Dimethicone Crosspolymer, Steareth-2, 1,2-Hexanediol, Lactic Acid, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Chlorphenesin

Product Labels Repair and Protect Moisturizer Broad Spectrum SPF30 (

76147-200-02)

INGREDIENTS AND APPEARANCE

REPAIR AND PROTECT MOISTURIZER BROAD SPECTRUM SPF30 
avobenzone, dimethicone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76147-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	15 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DOCOSANOL (UNII: 9G1OE216XY)
NYLON-12 (UNII: 446U8J075B)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-21 (UNII: 53J3F32P58)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
CLOVE (UNII: K48IKT5321)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ERYTHRITOL (UNII: RA96B954X6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAUROYL LYSINE (UNII: 113171Q70B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GUAR GUM (UNII: E89I1637KE)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
STEARETH-2 (UNII: V56DFE46J5)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76147-200-01	1 in 1 CARTON	03/18/2015
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 76147-200-02	1 in 1 CARTON	03/18/2015
2		7 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/18/2015

Labeler - Strivectin Operating Company, Inc. (832343722)