HYDRO AND PORE BB  - titanium dioxide, octinoxate and zinc oxide cream 
Inel Cosmetics Co., 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.

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Drug Facts

Titanium Dioxide 7.19%

Octinoxate 7.00%

Zinc Oxide 0.99%

Sunscreen

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two hours

- Use a water resistant sunscreen if swimming or sweating

Keep out of reach of children.

When using this product, keep out of eyes. Rinse with water to remove.

Water

Cyclomethicone 5

Glycerin

Dipropylene glycol

Isodecyl neopentanoate

Talc

Peg-10 Dimethicone (600 cst)

Arbutin

Dimethicone

Ferric oxide yellow

Distearyldimonium

Magnesium sulfate

C12-14 Pareth-3

Purslane

Phenoxyethanol

Triethoxycaprylylsilane

Palmitic Acid

Ferric Oxide Red

Ethylheylglycerin

.Alpha, -Tocopherol acetate

Ferrosoferric oxide

Methicone (20 cst)

Adenosine

Aminopropyl dihydrogen phosphate

Polymethysilsesquioxane (4.5 microns)

Caviar, unspecified

centella asiatica

Hibiscus sabdariffa flower

hyaluronic acid

Mentha x rotundifolia leaf

morinda citrifolia leaf

undaria pinnatifida

butylene glycol

hyssopus officinalis flowering top

prunus serrulata flower

castanea sativa leaf

morus alba leaf

phellinus linteus mycelium

plantago asiatica

menthyl pyrrolidone carboxylate, (-), dl-

citrus aurantium flower

citrus bergamia leaf

fennel seed

helichrysum italicum flower

jasminum officinale flower

laminaria digitata

lavandula angustifolia flowering top

melaleuca alternifolia leaf

pelargonium graveolens flowering top

pinus densiflora root

ethyl menthane carboxamide


image of hydro pore bb
HYDRO AND PORE BB  
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43526-107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.876 mg  in 40 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE2.8 mg  in 40 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide0.396 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
GLYCERIN 
DIPROPYLENE GLYCOL 
ISODECYL NEOPENTANOATE 
TALC 
PEG-10 DIMETHICONE (600 CST) 
ARBUTIN 
DIMETHICONE 
FERRIC OXIDE YELLOW 
DISTEARYLDIMONIUM 
MAGNESIUM SULFATE 
C12-14 PARETH-3 
PURSLANE 
PHENOXYETHANOL 
TRIETHOXYCAPRYLYLSILANE 
PALMITIC ACID 
FERRIC OXIDE RED 
ETHYLHEXYLGLYCERIN 
.ALPHA.-TOCOPHEROL ACETATE 
FERROSOFERRIC OXIDE 
METHICONE (20 CST) 
ADENOSINE 
AMINOPROPYL DIHYDROGEN PHOSPHATE 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
CAVIAR, UNSPECIFIED 
CENTELLA ASIATICA 
HIBISCUS SABDARIFFA FLOWER 
HYALURONIC ACID 
MENTHA X ROTUNDIFOLIA LEAF 
MORINDA CITRIFOLIA LEAF 
UNDARIA PINNATIFIDA 
BUTYLENE GLYCOL 
HYSSOPUS OFFICINALIS FLOWERING TOP 
PRUNUS SERRULATA FLOWER 
CASTANEA SATIVA LEAF 
MORUS ALBA LEAF 
PHELLINUS LINTEUS MYCELIUM 
PLANTAGO ASIATICA 
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- 
CITRUS AURANTIUM FLOWER 
CITRUS BERGAMIA LEAF 
FENNEL SEED 
HELICHRYSUM ITALICUM FLOWER 
JASMINUM OFFICINALE FLOWER 
LAMINARIA DIGITATA 
LAVANDULA ANGUSTIFOLIA FLOWERING TOP 
MELALEUCA ALTERNIFOLIA LEAF 
PELARGONIUM GRAVEOLENS FLOWERING TOP 
PINUS DENSIFLORA ROOT 
ETHYL MENTHANE CARBOXAMIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-107-021 in 1 CARTON
1NDC:43526-107-0140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2013
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Inel Cosmetics Co., Ltd.688038939manufacture(43526-107)

Revised: 1/2013
Document Id: 824b5aba-191b-49c2-af2d-5fa700596a1f
Set id: 72882999-f7df-4597-9765-b133dd6ce2ee
Version: 1
Effective Time: 20130125
 
Inel Cosmetics Co., Ltd.