BROAD SPECTRUM SPF 30 UP THE ANTI- titanium dioxide, zinc oxide cream

Broad Spectrum SPF 30 Up The Anti by

Drug Labeling and Warnings

Broad Spectrum SPF 30 Up The Anti by is a Otc medication manufactured, distributed, or labeled by Biopelle, Inc., Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Broad Spectrum SPF 30 Up The Anti

Active Ingredients

Zinc Oxide 6.0%
Titanium Dioxide 3.2%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protections 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply to face and under throat after cleansing
• reapply:
• • after excessive perspiration
• 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 15 or higher and other sun protection measures including:
• • limit time in the sun, especially from 10 a.m.  - 2 p.m.
  • wear long sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor
  

Inactive Ingredients

water, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl  peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.

Other Information

• protect this product from excessive heat and direct sun
  

Questions or comments?

Call toll free 1-866-424-6735 (weekdays)

SPL UNCLASSIFIED SECTION

PRESCRIBEDsolutions is Distributed By Biopelle, Inc.

A Ferndale Pharma Group Company, Ferndale, MI 48220

Made In USA

Broad Spectrum SPF 30 Up The Anti 75ml (

42485-005-01)

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 30 UP THE ANTI 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42485-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOHEXADECANE (UNII: 918X1OUF1E)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM ANISATE (UNII: F9WFJ28MV9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PANTHENOL (UNII: WV9CM0O67Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42485-005-01	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/14/2012

Labeler - Biopelle, Inc. (808158823)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(42485-005)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(42485-005)