OTC Medication Information: Surfers Skin Sunscreen

SURFERS SKIN SUNSCREEN — octinoxate, oxybenzone, titanium dioxide and zinc oxide cream
Skin Alive, Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

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

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

Surfersskin Sunscreen
(click image for full-size original)

Surfersskin Sunscreen
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 3.45 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1 mL in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.95 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
CYCLOMETHICONE
WATER
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
POLYSORBATE 60
VITAMIN A PALMITATE
SORBITAN MONOSTEARATE
ALPHA-TOCOPHEROL ACETATE
HONEY
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75916-4019-4 125 mL in 1 TUBE None
2 NDC:75916-4019-1 1 TUBE (TUBE) in 1 BOX contains a TUBE
2 40 mL in 1 TUBE This package is contained within the BOX (75916-4019-1)
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)

Revised: 01/2011 Skin Alive, Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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