BB CREAM SPF 20 BEIGE- octinoxate, octisalate, oxybenzone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 6.0%, Octisalate 4.0%, Oxybenzone 3.5%
Available from:
J. A. Cosmetics U.S. INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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.
Authorization status:
OTC monograph not final
Authorization number:
76354-863-01

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BB CREAM SPF 20 BEIGE- octinoxate, octisalate, oxybenzone cream

J. A. Cosmetics U.S. 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.

----------

BB Cream SPF 20 Beige

Drug Facts

Active ingredients

Octinoxate 6.0%

Octisalate 4.0%

Oxybenzone 3.5%

Purpos e

Sunscreen

Us es

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 exposure

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 sun 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 shirt, pants, hats and sunglasses

children under 6 months of age: Ask doctor.

Inactive ingredients

Water (Aqua), Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone,

Cydopentasiloxane, Cyclohexasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride,

Quatemium-18 Bentonite, Quartz, Triethoxycaprylylsilane, Zinc Stearate, Talc, Vp/Hexadecene

Copolymer, Bisabolol, Tocopheryl Acetate (Ve), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe

Barbadensis Leat Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Butylene Glycol,

Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Fragrance (Parfum) May Contain: Iron Oxides

(Cl 77491, Cl 77492, Cl 77499), Titanium Dioxide (Cl 77891)

Questions or comments?

1-855-353-7320

Principal Display Panel - 28.5 mL Carton Label

e .l.f.

BB CREAM

SPF 20

sunscreen

BEIGE

NET 0.96 FL. OZ. (28.5mL)

BB CREAM SPF 20 BEIGE

octinoxate, octisalate, oxybenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 354-8 6 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 0 mg in 1 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

35 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

SO RBITAN O LIVATE (UNII: MDL271E3GR)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

BENTO Q UATAM (UNII: 7F46 5U79 Q1)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ZINC STEARATE (UNII: H9 2E6 QA4FV)

TALC (UNII: 7SEV7J4R1U)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

JO JO BA O IL (UNII: 724GKU717M)

CUCUMBER (UNII: YY7C30 VXJT)

WATER (UNII: 0 59 QF0 KO0 R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MICA (UNII: V8 A1AW0 8 8 0 )

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CYCLO METHICO NE 6 (UNII: XHK3U310 BA)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

VINYLPYRRO LIDO NE/HEXADECENE CO PO LYMER (UNII: KFR5QEN0 N9 )

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

LEVO MENO L (UNII: 24WE0 3BX2T)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:76 354-8 6 3-0 1 28 .5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /26 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 6 /26 /20 18

Labeler -

J. A. Cosmetics U.S. INC (186705047)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co lumbia Co smetics Manufacturing, Inc.

0 6 8 26 78 6 3

ma nufa c ture (76 354-8 6 3)

J. A. Cosmetics U.S. INC

Revised: 12/2020

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