SURFERS SKIN SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Surfers Skin Sunscreen by

Drug Labeling and Warnings

Surfers Skin Sunscreen by is a Otc medication manufactured, distributed, or labeled by Skin Alive, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients

Octinoxate 7.5%

Oxybenzone 3.45%

Titanium Dioxide 1%

Zinc Oxide 1.95%

Purpose

Purpose

Sunscreen

Uses

Helps prevent Sunburn

Higher SPF gives more sunburn protection

Provides high protection against sunburn

Retains SPF after 80 minutes of swimming

Warnings

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.

When using this product

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Irritation occurs or rash develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

Apply generously 15 min before sun exposure and as needed.

Children under 6 months of age: ask a doctor.

Reapply as needed or after towel drying, swimming, or sweating

Inactive Ingredients

Aloe Vera Gel, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cyclomethicone, Deionised Water, Fragrance, Glyceryl Monostearate, Phenoxyethanol, Polysorbate 60, PVP?ejcosene, Retinol Palminate, Sorbitan Monostearate, Tocopherol Acetate, UMF 18 Manuka Honey

DESCRIPTION

Surfersskin SPF 30+ Sunscreen, VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM, UVA/UVB PROTECTION. keep your "Skin Alive" with this non greasy sweat resistant formula that won't runinto your eyes and give you up to 80 mins protection in the water.

Made in NZ

Skin alive

Expires:
Lot Number

www.surfersskin.co

DIST. BY: Quiver Dist., Bend Oregon, USA 97701

AS/ANZ STANDARD 2604-1998

4.2 fl oz (125ml)

To report a serious adverse event, contact 1-800-332-1088

PRINCIPAL DISPLAY PANEL

spf 30+

very water/sweat resistant

broad spectrum

UVA/UVB Protection

Surfersskin Sunscreen

Proven in Extreme New Zealand conditions

4.2 fl oz (125ml)

manuka honey UMF 18

CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURFERS SKIN SUNSCREEN 
octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75916-4019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.45 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.95 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HONEY (UNII: Y9H1V576FH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75916-4019-4	125 mL in 1 TUBE
2	NDC: 75916-4019-1	1 in 1 BOX
2		40 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2011

Labeler - Skin Alive, Ltd. (593384746)