NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BLUSH 40ML SPF 50- titanium oxide, zinc oxide liquid

NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL by

Drug Labeling and Warnings

NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL by is a Otc medication manufactured, distributed, or labeled by Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Ingredients:
Titanium Dioxide 3.3%
Zinc Oxide 14.9%

Purpose

Sunscreen

USES

Uses: Helps prevent sunburn. If used as
directed with other sun protection measures
(see directions), decreases the risk of skin
cancer and early skin ageing caused by the sun.

WARNINGS

Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
If product is swallowed, get medical help or
contact a Poison Control Center right away.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
• Reapply after 80 minutes of swimming or sweating.
• Reapply immediately after towel drying.
• Reapply at least every 2 hours.
• Children under 3 years of age: 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 value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10.00AM - 2.00PM
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

Inactive Ingredients: Aluminium Hydroxide,
Butyloctyl Salicylate, C12-15 Alkyl Benzoate,
Coco-Caprylate/Caprate, Dimethicone, Ethylhexyl
Methoxycrylene, Ethylhexylglycerin, Hibiscus
sabdariffa Flower Extract, Hydroxyacetophenone,
Iron Oxides/(CI 77499, CI 77491, CI 77492),
Isododecane, Isostearic Acid, Lauryl PEG-8
Dimethicone, Magnesium Sulfate, Mica/CI 77019,
Phenoxyethanol, Polyglyceryl-3 Polyricinoleate,
Propanediol, Purified Water, Silica, Sodium
Hyaluronate, Stearic Acid, Tin Oxide, Titanium
dioxide/CI 77891

OTHER INFORMATION

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

USER SAFETY WARNINGS

Directions: Shake well before use.
Apply liberally and reapply every 80 minutes,
especially after swimming or towel drying.
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 lime in the sun,
especially from 10 am-2 pm Wear longsleeved
shirts, pants, hats, and sunglasses For
Children under 6 months of age ask a doctor

PURPOSE

Sunscreen

Label

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BLUSH 40ML  SPF 50
titanium oxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62282-982
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISODODECANE (UNII: A8289P68Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62282-982-01	40 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/01/2024
2	NDC: 62282-982-02	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/30/2023

Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho		929572014	manufacture(62282-982)