Dr Deep SUN: Package Insert and Label Information

DR DEEP SUN- octinoxate, zinc oxide and titanium dioxide cream
MineralHouse Corporation

Active Ingredients: Ethyhexyl Methoxycinnamate 7.5%, Zinc Oxide 4%, Titanium Dioxide 3.5%, Isoamyl p-Methoxycinnamate 3.5%

Direction:

– Spread over the skin that will be exposed to the sun. Gently rub into your skin until the white is gone.

– Apply sunscreen approximately 30 minutes before being in the sun (for best results) so that it can be absorbed by the skin and less likely to wash off when you perspire.

– Remember to reapply sunscreen after swimming or strenuous exercise.

– Apply sunscreen often throughout the day if you work outdoors, and wear hats and protective clothing.

Purpose: Sunscreen

Warnings:

– For external use only

– Do not use on wounds or damaged skin

When using this product, do not use other than directed

Stop using if allergic reaction or irritation occurs

Keep out of reach of children

– If swallowed, get medical help or contact a Poison Control Center immediately

Storage: Keep in a dry and cool place

Inactive Ingredients: Water, Cyclopentasiloxane, Disodium Phenyl Dibenzimidazole Tetrasulfonate, Dimethicone, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Sea Water, Triethanolamine, Sorbitan Sesquioleate, Arbutin, Methyl Methacrylate Crosspolymer, Sodium Chloride, Beeswax, Disteardimonium Hectorite, Aluminum Hydroxide, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Ozokerite, Stearic Acid, Perfume, PEG-10 Dimethicone Crosspolymer, Dimethicone/Methicone Copolymer, Magnolia Kobus Bark Extract, Salix Alba (Willow) Bark Extract, Camellia Sinensis Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Propolis Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Thujopsis Dolabrata Branch Extract

Box Label
(click image for full-size original)

DR DEEP SUN
dr deep sun cream cream
Product Information
Product Type Item Code (Source) NDC:76015-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.75 g in 50 g
ZINC OXIDE (ZINC CATION) ZINC CATION 2 g in 50 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.75 g in 50 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
BISDISULIZOLE DISODIUM
DIMETHICONE
CETYL ETHYLHEXANOATE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)
TROLAMINE
SORBITAN SESQUIOLEATE
ARBUTIN
METHYL METHACRYLATE
SODIUM CHLORIDE
YELLOW WAX
DISTEARDIMONIUM HECTORITE
ALUMINUM HYDROXIDE
USNEA BARBATA
ZANTHOXYLUM PIPERITUM FRUIT PULP
PULSATILLA KOREANA WHOLE
CERESIN
STEARIC ACID
PEG-10 DIMETHICONE (600 CST)
MAGNOLIA KOBUS BARK
SALIX ALBA BARK
GREEN TEA LEAF
PUMMELO
PROPOLIS WAX
MATRICARIA RECUTITA FLOWERING TOP
THUJOPSIS DOLABRATA LEAFY TWIG
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76015-102-01 50 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 09/24/2016
Labeler — MineralHouse Corporation (557802539)
Registrant — MineralHouse Corporation (557802539)
Establishment
Name Address ID/FEI Operations
MineralHouse Corporation 557802539 relabel, repack
Establishment
Name Address ID/FEI Operations
Beaubeau Co. 689778744 manufacture

Revised: 09/2016 MineralHouse Corporation

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