IN TRANSIT SKIN DEFENCE- avobenzone, octinoxate, octocrylene, oxybenzone cream

In Transit Skin Defence by

Drug Labeling and Warnings

In Transit Skin Defence by is a Otc medication manufactured, distributed, or labeled by THIS WORKS PRODUCTS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Avobenzone 3%

Octinoxate 7%

Octocrylene 9.5%

Oxybenzone 6%

Purpose

Sunscreen

Use

• 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 swallowed get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 10am to2pm.
• wear long-sleeved shirts, pants, hats and sunglasses.
• 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

Aqua (Water/Eau), Butyrospermum parkii (Shea) butter, Acacia decurrens/Jojoba/Sunflower seed cera (Wax/Cire)/Polyglyceryl-3 esters, Glycerin, Butylene glycol, Octyldodecanol, Tapioca starch, Phenoxyethanol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Glyceryl stearate SE, Stearic acid, Xylitylglucoside, Benzyl alcohol, Sodium stearoyl glutamate, Anhydroxylitol, Polyacrylamide, Xanthan gum, Echium plantagineum seed oil, Lecithin, Xylitol, C13-14 Isoparaffin, Disodium EDTA, Sodium hyaluronate, Theobroma cacao (Cocoa) seed butter, Tocopheryl acetate, Helianthus annuus (Sunflower) seed oil unsaponifiables, Polymethylsilsesquioxane, Dehydroacetic acid, Parfum (Fragrance), Laureth-7, Limonene, Ethylbisiminomethylguaiacol manganese chloride, Cardiospermum halicacabum flower/Leaf/Vine extract, Linalool, Tocopherol, Citrus aurantium amara (Bitter Orange) leaf/Twig oil, Citrus aurantium bergamia (Bergamot) peel oil, Citrus limon (Lemon) peel oil, juniperus virginiana (Cedarwood) wood oil, Citric acid.
*Naturally occuring i essential oils.

QUESTIONS

To report serious adverse even contact This Works Products Limited on 855-877-0555.

Package Labeling:

INGREDIENTS AND APPEARANCE

IN TRANSIT SKIN DEFENCE 
avobenzone, octinoxate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71278-006
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECANOL (UNII: 461N1O614Y)
STARCH, TAPIOCA (UNII: 24SC3U704I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XANTHAN GUM (UNII: TTV12P4NEE)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
XYLITOL (UNII: VCQ006KQ1E)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
LAURETH-7 (UNII: Z95S6G8201)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)
BERGAMOT OIL (UNII: 39W1PKE3JI)
LEMON OIL (UNII: I9GRO824LL)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71278-006-01	1 in 1 CARTON	05/17/2017
1		40 mL in 1 TUBE; 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	05/17/2017

Labeler - THIS WORKS PRODUCTS LIMITED (211715561)