OP PROTECT AND NOURISH BABIES AND SENSITIVE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

OP Protect and Nourish Babies and Sensitive SPF 50 by

Drug Labeling and Warnings

OP Protect and Nourish Babies and Sensitive SPF 50 by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC, KIK Custom Products – Rexdale plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OP Protect & Nourish Babies & Sensitive SPF 50

Active Ingredients

Avobenzone 3.0%

Active Ingredients

Homosalate 15.0%

Active Ingredients

Octisalate 5.0%

Active Ingredients

Octocrylene 7.0%,

Purpose

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if 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.

Directions:

Apply liberally 15 minutes before sun exposure.

Re-apply:

      after 80 minutes of swimming or sweating

      immediately after towel drying

      at least every 2 hours

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

Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Idopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Propylene Glycol, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water

Other Information:

For use on skin only. Avoid contact with fabric.

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Ocean Potion
Protect
& Nourish
Vitamin D3
Babies &
Sensitive
SPF 50
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

OP PROTECT AND NOURISH BABIES AND SENSITIVE SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYPROMELLOSES (UNII: 3NXW29V3WO)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-215-24	227 g in 1 CONTAINER; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Custom Products – Rexdale plant		243547333	ANALYSIS(70281-215) , MANUFACTURE(70281-215)