OTC Medication Information: W HONEY BEAM CUSHION 21

W HONEY BEAM CUSHION 21- titanium dioxide, octinoxate, octisalate, octocrylene and zinc oxide powder
WOW VENTURES

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 INGREDIENT

Active Ingredient: Titanium Dioxide 9.00%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.80%, Octocrylene 2.00%, Zinc Oxide 2.00%

INACTIVE INGREDIENT

Inactive Ingredients: Honey Extract, Cyclopentasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cyclohexasiloxane, C12-15 Alkyl benzoate, Niacinamide, Trimethylsiloxysilicate, PEG-30 Dipolyhydroxystearate, PEG-10 Dimethicone, Sodium Chloride, Dimethicone, Quaternium-18 Bentonite, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Chlorphenesin, Triethoxycaprylylsilane, Aluminum Hydroxide, Perfume, Iron Oxides (CI 77499), Adenosine, Honey, Magnesium Ascorbyl Phophate, Hippophae Rhamnoides Fruit Extract, Tocopheryl Acetate, Panthenol, Water, Juniperus Communis Fruit Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Salvia Sclarea (Clary) Oil, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If any of the following symptoms appear on the area where the product was applied, stop using the product immediately and consult a specialist. A. Several skin conditions including rash, swelling, irritation, and stimulation B. When above symptoms occur while sun rays are applied 2. Do NOT use on the area with scars, eczema or dermatitis 3. Storage and dealings warnings. A. Close tight after use B. Keep out of reach of children C. Do not keep the product in high or low temperature and keep out of sun

DESCRIPTION

Directions & Usage: Apply a suitable amount to your face or hand. Tap or spread gently.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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W HONEY BEAM CUSHION 21
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69894-040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 1.35 g in 15 g
Octinoxate (OCTINOXATE) Octinoxate 1.05 g in 15 g
Octisalate (OCTISALATE) Octisalate 0.72 g in 15 g
Octocrylene (OCTOCRYLENE) Octocrylene 0.3 g in 15 g
Zinc Oxide (ZINC CATION) ZINC CATION 0.3 g in 15 g
Inactive Ingredients
Ingredient Name Strength
Honey
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69894-040-01 15 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2015
Labeler — WOW VENTURES (688731080)
Registrant — WOW VENTURES (688731080)
Establishment
Name Address ID/FEI Operations
WOW VENTURES 688731080 manufacture (69894-040)

Revised: 06/2015 WOW VENTURES

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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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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