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NDC 71388-0001-00 BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus 78.2; 9.6 mg/g; mg/g Details

BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus 78.2; 9.6 mg/g; mg/g

BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Beauty Be Co., Ltd. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	71388-0001
Product ID	71388-001_7e0447f6-de04-5089-e053-2a91aa0a8b56
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	78.2; 9.6
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Beauty Be Co., Ltd
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71388-0001-00 (71388000100)

Pricing Information	N/A
NDC Package Code	71388-001-00
Billing NDC	71388000100
Package	1 TUBE in 1 BOX (71388-001-00) / 30 g in 1 TUBE
Marketing Start Date	2017-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4d257210-2038-3283-e054-00144ff88e88 Details

Drug Facts

Active ingredients

Titanium dioxide 7.82%

Zinc Oxide 0.96%

Purpose

Sunscreen

Uses

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

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 skin 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 shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Cyclomethicone, Dimethicone Crosspolymer, Cyclopentasiloxane, PEG-10 Dimethicone, Alumina, Methicone, Water, Simethicone, Phenyl Trimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Acrylates/Dimethicone Copolymer, Tocopheryl Acetate, Hexyldecanol, Crab Apple (Pyrus malus) Seed Extract, Caprylic/Capric Triglyceride, Diacetyl Boldine, Strawberry (Fragaria vesca) Fruit Extract, Blueberry (Vaccinium angustifolium) Fruit Extract, Blackberry (Rubus corchorifolius) Fruit Extract, Raspberry (Rubus

occidentalis) Fruit Extract, Cranberry (Vaccinium macrocarpon) Fruit Extract, Melanin, Pentylene Glycol, Ethylhexylglycerine, Silica, Nylon-12, Polymethylsilsesquioxane, Jojoba (Simmondsia chinensis) Seed Oil, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Talc, Iron Oxides (CI 77491), Iron Oxides (CI 77492)

Package Labeling:

INGREDIENTS AND APPEARANCE

BB CARE ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 PLUS

titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71388-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78.2 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHICONE (20 CST) (UNII: 6777U11MKT)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLDECANOL (UNII: 151Z7P1317)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
ALPINE STRAWBERRY (UNII: CG6IX3GCMU)
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)
BLACKBERRY (UNII: 8A6OMU3I8L)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
JOJOBA OIL (UNII: 724GKU717M)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71388-001-00	1 in 1 BOX	04/14/2017
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/14/2017

Labeler - Beauty Be Co., Ltd (662340075)

Revised: 12/2018

Document Id: 7e0447f6-de04-5089-e053-2a91aa0a8b56

Set id: 4d257210-2038-3283-e054-00144ff88e88

Version: 2

Effective Time: 20181227