CLOUD 9 100% MINERAL SUN BALM BROAD SPECTRUM SUNSCREEN SPF 40- titanium dioxide, zinc oxide cream

Cloud 9 100% Mineral Sun Balm Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Cloud 9 100% Mineral Sun Balm Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Gordon Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 1.14%, Zinc Oxide 20.4% 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.

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

Stop use and ask a doctor if rash occurs.

Warnings

For external use only. Do not use on damaged or broken skin. When using the 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 Poison Control Center right away.

Directions

• Apply generously and evenly 15 minutes before sun exposure
• 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 value 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

Inactive Ingredients

Adansonia Digitata (Baobab) Seed Oil, Astrocaryum Murumuru Seed Butter, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Calendula Officinalis (Calendula) Extract, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Seed Wax, Hippophae Rhamnoides (Sea Buckthorn) Seed Oil, Hydrogenated Rapeseed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Rosa Alba (White Rose) Leaf Cell Extract, Rosa Canina (Rose Hip) Fruit Oil, Silica, Stearic Acid

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

Questions or commnets? Contact our Sun Specialists 877-564-7330

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

PRINCIPAL DISPLAY PANEL

CLOUD 9

100% MINERAL SUN BALM

Broad Spectrum Sunscreen SPF 40 PA+++

Cloud 9 100% Mineral Sun Balm SPF 40 is a pocket-friendly formula that leaves your skin feeling like it's on, well, cloud nine. Use it wherever you need some serious protection, soothing and nourishment, but definitely don't forget about spots like your ears and hands that may require little extra TLC.

supergoop.com Distributed by Taylor James, LLC. San Antonio, TX 78215

SPF 40

Cruelty free

1 oz./28.7g

100% Mineral Sunscreen Actives. Reef-Safe. Non-Irritating. No Synthetic Fragrance. Vegan.

INGREDIENTS AND APPEARANCE

CLOUD 9 100% MINERAL SUN BALM BROAD SPECTRUM SUNSCREEN SPF 40 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.14 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
1,3-BUTYLENE GLYCOL 1-STEARATE (UNII: UZQ17K3ERJ)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
COCONUT OIL (UNII: Q9L0O73W7L)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-512-01	28.7 g in 1 CONTAINER; Type 0: Not a Combination Product	08/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/20/2020

Labeler - Supergoop, LLC (117061743)