BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 CASHEW 3.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 CINNAMON 10.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 CEDAR 11- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 MAHOGANY 11.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 BAMBOO 5.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 BIRCH 1.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 DESERT 6.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 DUNE 7.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 WHEAT 4.5- titanium dioxide gel BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30 TERRA 8.5- titanium dioxide gel

bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 by

Drug Labeling and Warnings

bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(s)

Titanium dioxide 6.2%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor
• 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 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

Inactive ingredients

water, coconut alkanes, propanediol, squalane, trehalose, isostearic acid, glycerin, silica, agar, caprylic/capric triglyceride, globularia cordifolia callus culture extract, salicornia herbacea extract, melilotus officinalis extract, coco-caprylate/ caprate, butylene glycol, lauroyl lysine, sodium hyaluronate, succinoglycan, polysorbate 60, cellulose gum, polyglyceryl-4 laurate/succinate, sorbitan sesquiisostearate, magnesium stearate, magnesium hydroxide, magnesium chloride, potassium chloride, calcium chloride, potassium sorbate, phenoxyethanol. may contain: titanium dioxide, iron oxides.

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

SPL UNCLASSIFIED SECTION

Dist. by bareMinerals, New York, NY 10022,
USA

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Cashew 3.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Cinnamon 10.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Cedar 11

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Mahogany 11.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Bamboo 5.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Birch 1.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Desert 6.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Dune 7.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Wheat 4.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Box - Terra 8.5

bareMinerals®

COMPLEXION
RESCUE™

TINTED HYDRATING
GEL CREAM

BROAD SPECTRUM
SPF 30

35 ml / 1.18 fl. oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   CASHEW 3.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-274
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-274-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   CINNAMON 10.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-275-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   CEDAR 11
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-276-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   MAHOGANY 11.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-277-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   BAMBOO 5.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-278-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   BIRCH 1.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-279
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-279-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   DESERT 6.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-280-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   DUNE 7.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-281-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   WHEAT 4.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-282-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

BAREMINERALS COMPLEXION RESCUE TINTED HYDRATING BROAD SPECTRUM SPF 30   TERRA 8.5
titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
coconut alkanes (UNII: 1E5KJY107T)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
trehalose (UNII: B8WCK70T7I)
isostearic acid (UNII: X33R8U0062)
glycerin (UNII: PDC6A3C0OX)
silicon dioxide (UNII: ETJ7Z6XBU4)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
medium-chain triglycerides (UNII: C9H2L21V7U)
salicornia europaea (UNII: 6ADL50JAKW)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol (UNII: 3XUS85K0RA)
lauroyl lysine (UNII: 113171Q70B)
hyaluronate sodium (UNII: YSE9PPT4TH)
polysorbate 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
magnesium hydroxide (UNII: NBZ3QY004S)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-283-10	1 in 1 BOX	12/01/2019
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2019

Labeler - Bare Escentuals Beauty, Inc. (087008363)