OTC Medication Information: Naked Skin One and Done, Medium Dark

NAKED SKIN ONE AND DONE, MEDIUM DARK- zinc oxide and octinoxate cream
Autumn Harp Inc.

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.

DRUG FACTS:

Active Ingredients:

Octinoxate 7.5%

Zinc Oxide 3.4%

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. 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:

For sunscreen use: Apply liberally 15 minutes before sun exposer. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 of age: Ask a doctor.

Other Information:

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

Inactive Ingredients:

Water, Isododecane, Cyclopentasiloxane, Adipic Acid / Neopentyl Glycol Crosspolymer, Lauryl Dimethicone, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Polyglyceryl-6 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isononyl Isononanoate, Propylene Glycol, Hydrogenated Polyisobutene, Iron Oxide (CI 77492), Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isopropyl Myristate, Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI 77491), Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Iron Oxides (CI 77499), Silica, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Triethoxycaprylylsilane, Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Propylene Carbonate, Dimethylcyclosiloxane, Polyhydroxystearic Acid, BHT, Sorbic Acid.

Questions or comments?

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NAKED SKIN ONE AND DONE, MEDIUM DARK
spf cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0346
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.4 g in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ISODODECANE
LAURYL TRISILOXANE
FERROSOFERRIC OXIDE
SODIUM CHLORIDE
XANTHAN GUM
ISOPROPYL TITANIUM TRIISOSTEARATE
SILICON DIOXIDE
TRIETHOXYCAPRYLYLSILANE
POLYHYDROXYSTEARIC ACID (2300 MW)
PROPYLENE CARBONATE
ALOE VERA LEAF
BUTYLATED HYDROXYTOLUENE
SORBIC ACID
POLYGLYCERYL-2 MONOISOSTEARATE
WATER
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)
PROPYLENE GLYCOL
GLYCERIN
PHENOXYETHANOL
GLYCYRRHIZA GLABRA
TETRADIUM RUTICARPUM FRUIT
TITANIUM DIOXIDE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
ISONONYL ISONONANOATE
CYCLOMETHICONE 5
CYCLOMETHICONE 4
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
HYDROGENATED POLYBUTENE (1300 MW)
PROPANEDIOL
ISOPROPYL MYRISTATE
DISTEARDIMONIUM HECTORITE
ASPERGILLUS FUMIGATUS
ISOCETETH-10
STEARALKONIUM HECTORITE
DIETHYLENE GLYCOL MONOETHYL ETHER ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51514-0346-0 40 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/04/2016
Labeler — Autumn Harp Inc. (064187883)
Establishment
Name Address ID/FEI Operations
Autumn Harp Inc. 064187883 manufacture (51514-0346)

Revised: 09/2019 Autumn Harp Inc.

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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