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 Type HUMAN OTC DRUG Item Code (Source) NDC:43526-107
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.876 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.8 mg  in 40 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.396 mg  in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
TALC (UNII: 7SEV7J4R1U)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ARBUTIN (UNII: C5INA23HXF)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARYLDIMONIUM (UNII: 251IW5I21C)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
C12-14 PARETH-3 (UNII: 93RY22U87E)  
PURSLANE (UNII: M6S840WXG5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PALMITIC ACID (UNII: 2V16EO95H1)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ADENOSINE (UNII: K72T3FS567)  
AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
CASTANEA SATIVA LEAF (UNII: IV3S2HH53G)  
MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C)  
PLANTAGO ASIATICA (UNII: 5F5728J5E8)  
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
CITRUS BERGAMIA LEAF (UNII: ZGS96VDV4T)  
FENNEL SEED (UNII: G3QC02NIE6)  
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
PINUS DENSIFLORA ROOT (UNII: 23O27N8142)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43526-107-02 1 in 1 CARTON
1 NDC:43526-107-01 40 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/25/2013
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
Name Address ID/FEI Business Operations
Inel Cosmetics Co., Ltd. 688038939 manufacture(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.