Drug Facts

Active Ingredients

Octinoxate 4.5%,
Zinc Oxide 9.5%

Purpose

Sunscreen

Uses

helps prevent sunburn.
if used as directed with other sun protection measures (see Directions), helps decrease 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 two 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
Children under 6 months: ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

Water/Aqua, Caprylic/Capric Triglyceride, Dimethicone, Dimethyl Isosorbide, Methyl Gluceth-20, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Cetearyl Alcohol, Hydrolyzed Pearl, Juglans Regia (Walnut) Seed Extract, Sodium Hyaluronate Crosspolymer, Silanetriol, Lavandula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolmer, Polyhydroxystearic Acid, Squalane, Triethoxycaprylylsilane, Polysorbate 60, Cetyl Alcohol, Silica Dimethyl Silylate, Magnesium Aluminum Silicate, Pentylene Glycol, Ethylhexylglycerin, Disodium EDTA, Silica, Phenoxyethanol, Tin Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Questions?

1-800-831-5150 in USA

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light

sheer
tint

spf
20

broad
spectrum

light

1.3 US FL OZ / 40 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium

sheer
tint

spf
20

broad
spectrum

medium

1.3 US FL OZ / 40 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark

sheer
tint

spf
20

broad
spectrum

dark

1.3 US FL OZ / 40 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark

SHEER TINT SPF20 - LIGHT
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68479-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	95 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Methyl Gluceth-20 (UNII: J3QD0LD11P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Stearic Acid (UNII: 4ELV7Z65AP)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Calcium Carbonate (UNII: H0G9379FGK)
English Walnut (UNII: 1V3SHR7QB7)
PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)
Silanetriol (UNII: E52D0J3TS5)
Lavender Oil (UNII: ZBP1YXW0H8)
Lavandin Oil (UNII: 9RES347CKG)
Eucalyptus Oil (UNII: 2R04ONI662)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Squalane (UNII: GW89575KF9)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetyl Alcohol (UNII: 936JST6JCN)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Pentylene Glycol (UNII: 50C1307PZG)
Ethylhexylglycerin (UNII: 147D247K3P)
Edetate Disodium (UNII: 7FLD91C86K)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Stannic Oxide (UNII: KM7N50LOS6)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (Skin Tone Light)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68479-201-02	1 in 1 CARTON	01/22/2015
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:68479-201-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	01/22/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/22/2015

SHEER TINT SPF20 - MEDIUM
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68479-901
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	95 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Methyl Gluceth-20 (UNII: J3QD0LD11P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Stearic Acid (UNII: 4ELV7Z65AP)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Calcium Carbonate (UNII: H0G9379FGK)
English Walnut (UNII: 1V3SHR7QB7)
PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)
Silanetriol (UNII: E52D0J3TS5)
Lavender Oil (UNII: ZBP1YXW0H8)
Lavandin Oil (UNII: 9RES347CKG)
Eucalyptus Oil (UNII: 2R04ONI662)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Squalane (UNII: GW89575KF9)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetyl Alcohol (UNII: 936JST6JCN)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Pentylene Glycol (UNII: 50C1307PZG)
Ethylhexylglycerin (UNII: 147D247K3P)
Edetate Disodium (UNII: 7FLD91C86K)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Stannic Oxide (UNII: KM7N50LOS6)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (Skin Tone Medium)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68479-901-02	1 in 1 CARTON	01/22/2015
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:68479-901-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/2015
3	NDC:68479-901-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	01/22/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/22/2015

SHEER TINT SPF20 - DARK
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68479-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	95 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Methyl Gluceth-20 (UNII: J3QD0LD11P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Stearic Acid (UNII: 4ELV7Z65AP)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Calcium Carbonate (UNII: H0G9379FGK)
English Walnut (UNII: 1V3SHR7QB7)
PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)
Silanetriol (UNII: E52D0J3TS5)
Lavender Oil (UNII: ZBP1YXW0H8)
Lavandin Oil (UNII: 9RES347CKG)
Eucalyptus Oil (UNII: 2R04ONI662)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Squalane (UNII: GW89575KF9)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetyl Alcohol (UNII: 936JST6JCN)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Pentylene Glycol (UNII: 50C1307PZG)
Ethylhexylglycerin (UNII: 147D247K3P)
Edetate Disodium (UNII: 7FLD91C86K)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Stannic Oxide (UNII: KM7N50LOS6)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (Skin Tone Dark)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68479-301-02	1 in 1 CARTON	01/22/2015
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:68479-301-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	01/22/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/22/2015

Labeler - Dermalogica, Inc. (177698560)

Name	Address	ID/FEI	Business Operations
Establishment
Cosway		620899877	MANUFACTURE(68479-201, 68479-901, 68479-301)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Wipes		161104729	MANUFACTURE(68479-201, 68479-901, 68479-301)

Sheer Tint SPF20

Active Ingredients

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a Doctor

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark

Sheer Tint
SPF20