Fair Light Tinted Drops by Make2Give LLC Fair/Light Tinted Drops

Drug Details [pdf]

FAIR LIGHT TINTED DROPS- titanium dioxide, zinc oxide lotion
Make2Give LLC

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Fair/Light Tinted Drops

Drug Facts

Active Ingredients

Titanium Dioxide 6%

Zinc Oxide 6%

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.

When using this product

keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor

if a rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions

Apply liberally and spread evenly 15 minutes before sun exposure and as needed.
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 of 15 or higher and other sun protection measures including limit time in the sun, especially from 10 am- 2pm wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, C13-14 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecnate, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Iron Oxides, lsopropyl Myristate, Lecithin, Mangifera lndica (Mango) Butter, Propylene Carbonate, Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Sodium Polyacrylate, Stearalkonium Hectorite, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol, Caramel Color.

Other Information

Protect the product from excessive heat and direct sun.

Package Labeling:

Label Label2

FAIR LIGHT TINTED DROPS
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75796-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATERMELON (UNII: 231473QB6R)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT (UNII: L56Z1JK48B)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ETHYL VANILLIN (UNII: YC9ST449YJ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MANGO (UNII: I629I3NR86)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
POMEGRANATE (UNII: 56687D1Z4D)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75796-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	10/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/01/2020	10/05/2023

Labeler - Make2Give LLC (023910159)

Revised: 10/2023

Document Id: 079f15aa-2ffd-e231-e063-6294a90a683b

Set id: efdbd781-aa5e-4734-a842-3e5954409dae

Version: 3

Effective Time: 20231013