EARTH AND VINE BB BROAD SPECTRUM SPF 15 SUNSCREEN- octinoxate and titanium dioxide cream

Earth and Vine BB Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Earth and Vine BB Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate, 4.0%

Titanium Dioxide, 2.1%

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use water resistant sunscreen if swimming or sweating
• Children under 6 months 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 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, talc, C12-15 Alkyl benzoate, caprylic/capric triglyceride, potassium cetyl phosphate, cyclopentasiloxane, glyceryl myristate, isononyl isononanoate, behenyl alcohol, mineral oil, glycerin, propylene glycol, microcrystalline cellulose, cellulose gum, phenoxyethanol, ethylhexylglycerin, malus domestica fruit cell culture, xanthan gum, lecithin, nylon-12, triethanolamine, ammonium acryloyldimethyltaurate/VP copolymer, iron oxides, fragrance, butylene glycol, allantoin, caffeine, ascorbic acid, disodium EDTA, tocopheryl acetate (vitamin E), chamomilla recutita (matricaria) flower extract, persea gratissima (avocado) oil, cucumis sativus (cucumber) fruit oil, ginkgo biloba leaf extract, butyrospermum parkii (shea butter), simmondsia chinensis (jojoba) seed oil, BHT, camellia sinensis leaf extract, hyaluronic acid.

Package/Label Principal Display Panel

Earth & Vine™
AGE-DEFYING SKINCARE

SKIN
ILLUMINATOR
BB CREAM
SPF 15

• Brightens & evens skin tone
• Formulated with powerful antioxidants
• Broad Spectrum SPF15
• Light/Medium skin tone
• Enhanced with Nutriplex™
  • a skin nutrition complex

2.5 fl oz
75 mL

Return your skin’s appearance to its original radiant self with Earth & Vine™ Skin Illuminator BB Cream. This BB Cream combines apple stem cells with broad spectrum SPF15 and additional anti-aging ingredients to awaken skin, even skin tone and brightens for smooth, natural looking skin

Directions:
Apply liberally 15 minutes before sun exposure. Reapply every 2 hours. Use water resistant sunscreen if swimming or sweating.
Children under 6 months: Ask a doctor

How Can Apples Deliver Beautiful Skin?

Earth & Vine™ is a collection of skincare products uniquely formulated with the stem cells of Uttwiler Spätlauber, a rare Swiss apple with origins dating to the mid-18th century. Long known for its ability to be stockpiled without withering or showing “signs of aging.” Today, this exceptional gift of nature is recognized for its ability to maintain the vibrancy and freshness of skin. Treat your skin with “an apple a day” to awaken dormant skin cells, and to combat chronological aging of the skin.

Earth & Vine™ is a collection of skin care products that are uniquely formulated to harness the power of fruit stem cells – nature’s greatest weapon against the aging process. Apple stem cells which are known for their anthocyanins – powerful antioxidants that help protect skin from UV radiation, premature photo-aging, oxidative stress. When blended with other organic anti-aging ingredients, skin looks naturally younger by diminishing the appearance of fine lines and wrinkles, evens and brightens skin tone, and clarifies the complexion.

Nutriplex,™ our exclusive complex of a powerful, proprietary blend of the earth’s greatest nutrients and botanicals form a nutritious defense against the aging process.

• Rare Apple Stem Cells – for anti-aging & anti-wrinkles
• Chamomile – soothes and revitalizes skin
• Green Tea – contains anti-inflammatory properties that slow signs of aging
• Powerful Moisturizers including Shea Butter & Jojoba Oil to nourish and hydrate skin

Visit us at
www.earthandvineskincare.com

Made in Israel
Distributed by:
Emilia Personal Care
5890 Sawmill Road, Suite 230
Dublin, OH 43017

WD418 83 C1

Carton Label

INGREDIENTS AND APPEARANCE

EARTH AND VINE BB BROAD SPECTRUM SPF 15 SUNSCREEN 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TALC (UNII: 7SEV7J4R1U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MYRISTATE (UNII: 6992Y81827)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DOCOSANOL (UNII: 9G1OE216XY)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
APPLE (UNII: B423VGH5S9)
XANTHAN GUM (UNII: TTV12P4NEE)
NYLON-12 (UNII: 446U8J075B)
TROLAMINE (UNII: 9O3K93S3TK)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALLANTOIN (UNII: 344S277G0Z)
CAFFEINE (UNII: 3G6A5W338E)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
AVOCADO OIL (UNII: 6VNO72PFC1)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
GINKGO (UNII: 19FUJ2C58T)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-419-12	1 in 1 CARTON
1		75 g in 1 TUBE; 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	09/01/2014

Labeler - Emilia Personal Care Inc. (965445112)